FDA 510(k) Applications for Medical Device Product Code "EMA"
(Cement, Dental)

FDA 510(k) Number Applicant Device Name Decision Date
K973961 3M COMPANY 3M DENT SYSTEM II PLUS 12/17/1997
K864270 3M COMPANY 3M GLASS IONOMER LINER 12/16/1986
K902041 3M COMPANY 3M LUTING CEMENT - PASTE A AND PASTE B 06/27/1990
K911842 3M COMPANY 3M LUTING CEMENT, PASTE A AND B 06/17/1991
K170330 3M Company 3M Protemp Cement Temporary Dental Cement 02/06/2017
K002452 3M COMPANY 3M RELY X VENEER CEMENT TRY-IN PASTER 09/28/2000
K962065 3M COMPANY 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE 07/18/1996
K933139 3M COMPANY 3M VITREMER LUTING CEMENT 01/05/1994
K925032 3M COMPANY 3M VITREMER TRI-CURE GLASS IONOMER SYSTEM 12/23/1992
K011200 3M COMPANY GILB, MODEL 8010 06/14/2001
K052235 3M COMPANY LCR 09/27/2005
K022476 3M COMPANY RELYX RMGIP 08/02/2002
K153174 3M DEUTSCHLAND GMBH Ketac Universal Aplicap 04/13/2016
K110508 3M ESPE AG SUGLUE-10 06/03/2011
K100756 3M ESPE AG DENTAL PRODUCTS MALTA 06/02/2010
K094007 3M ESPE AG DENTAL PRODUCTS UNICEM 04/08/2010
K020256 3M ESPE AG DENTAL PRODUCTS UNICEM 03/25/2002
K100908 3M ESPE AG DENTAL PRODUCTS UNICEM HM 06/22/2010
K073395 3M ESPE DENTAL PRODUCTS GILB-2, GLASS IONOMER PROTECTIVE COATING 01/17/2008
K111185 3M ESPE DENTAL PRODUCTS RELYX LUTING PLUS AUTOMIX 05/05/2011
K062292 3M ESPE DENTAL PRODUCTS UNICEM 10/25/2006
K952121 3M MEDICAL PRODUCTS GROUP 3M RESIN CEMENT 06/22/1995
K991974 AB ARDENT FUTURA GLASS IONOMER SILVER REINFORCED 09/17/1999
K760978 ADP INTL., INC. ZINC CEMENT 11/15/1976
K020376 ADVANCED HEALTHCARE LTD. AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE 04/09/2002
K023981 ADVANCED HEALTHCARE LTD. AHL GENERIC GLASS IONOMER LUTING CEMENT 01/31/2003
K024287 ADVANCED HEALTHCARE LTD. FIXOBRIDGE 3-CEMENT 03/21/2003
K954177 ALPHA-BOND, INC. ALPHA-BOND DENTIN BONDING SYSTEM 09/27/1995
K954876 AMERICAN DENTAL PRODUCTS, INC. AMERICAN DENTAL PRODUCTS ROOT CANAL SEALER, WACH'S FORMULA 11/15/1995
K896249 AMERICAN ORTHODONTICS BANDTITE GLASS IONOMER CEMENT 01/26/1990
K972485 ARENT, FOX, KINTNER, PLOTKIN & KAHN CIMPAT N 09/08/1997
K870209 BIONEXUS, INC. NEXADENT (DENTAL CEMENT) 02/19/1987
K032597 BISCO, INC. BISCEM GI 11/04/2003
K060701 BISCO, INC. BISCEM TRANSLUCENT, BISCEM OPAQUE 05/15/2006
K082449 BISCO, INC. BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 09/25/2008
K940030 BISCO, INC. BISCO COMPOSITE 02/04/1994
K101787 BISCO, INC. DUOLINK II 10/08/2010
K011159 BISCO, INC. ONE-STEP PLUS 06/08/2001
K161256 BISCO, INC. TheraCem 07/29/2016
K813380 BITAN INT'L MARKETING CO. CAVIDENTIN 02/24/1982
K974097 BLACKLOCK MEDICAL PRODUCTS, INC. PERIACRYL 04/09/1998
K802662 BUFFALO DENTAL MFG. CO., INC. POLYCARBONATE TEMPORARY CEMENT 12/16/1980
K861685 CARLISLE LABORATORIES, INC. SUPERLON (UNILON) CARBOXYLATE CEMENT 05/19/1986
K003791 CAVEX HOLLAND B.V. CAVEX TEMPORARY CEMENT 01/23/2001
K980568 CENTRIX, INC. JUMBO GLASS IONOMER CEMENT 04/30/1998
K982665 CENTRIX, INC. JUMBO SILVER-REINFORCED GLASS IONOMER 09/08/1998
K931084 CENTRIX, INC. TEMPIT 05/27/1993
K922638 CENTRIX, INC. TEMPIT-E 08/10/1992
K921173 CENTRIX, INC. TYPE 1 DENTAL CEMENT 11/04/1992
K980159 CLOSURE MEDICAL CORP. OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01 04/09/1998
K881422 COE LABORATORIES, INC. COE PAK AUTO MIX, REGULAR OR HARD SET 10/31/1988
K902392 COLTENE, INC. COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL 08/28/1990
K072604 COLTENE/WHALEDENT AG DUO TEMP 11/16/2007
K160800 COLTENE/WHALEDENT AG DuoCem 11/16/2016
K053040 COLTENE/WHALEDENT AG PARACEM UNIVERSAL DC 11/09/2005
K121621 COLTENE/WHALEDENT AG SOLOCEM 01/08/2013
K083304 COLTENE/WHALEDENT AG TEMPOSIL 2 02/06/2009
K050426 COLTENE/WHALEDENT AG TEMPOSIL, MODEL 6720 03/18/2005
K031752 COLTENE/WHALEDENT INC. COLTOSOL F 08/05/2003
K993710 COLTENE/WHALEDENT INC. MODIFICATION OF PARAPOST CEMENT 12/21/1999
K945366 COLTENE/WHALEDENT INC. PARAPOST CEMENT 02/02/1995
K914324 CONFI-DENTAL PRODUCTS CO. CAVITY VARNISH PRODUCT 12/27/1991
K933199 CONFI-DENTAL PRODUCTS CO. CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL 01/06/1994
K914318 CONFI-DENTAL PRODUCTS CO. GLASS IONOMER CEMENT 03/20/1992
K940546 CONFI-DENTAL PRODUCTS CO. GRANITEC IONOMER RESIN CEMENT 04/29/1994
K894953 CONFI-DENTAL PRODUCTS CO. GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS 02/06/1990
K896649 CONFI-DENTAL PRODUCTS CO. GRANITEC Z2, ZINC PHOSPHATE CEMENT 02/22/1990
K902635 CONFI-DENTAL PRODUCTS CO. MODIFIED GRANITEC P2 & G2 DENTAL CEMENTS 07/10/1990
K902817 CONFI-DENTAL PRODUCTS CO. SURGI PAK NE AND COCOMENT EUGENAL FREE PASTE SYST 08/28/1990
K031494 COOLEY & COOLEY, LTD. DOC'S BEST WHITE COPPER CEMENT 11/12/2003
K821824 CORALITE DENTAL PRODUCTS, INC. TEM-STIK 07/06/1982
K924132 COSMEDENT, INC. E.Z. TEMEP, TEMPORARY FILLING MATERIAL 07/08/1993
K894477 COSMEDENT, INC. INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM 01/10/1990
K873356 COSMEDENT, INC. INSURE PORCELAIN VENEER BONDING SYSTEM 12/29/1987
K122974 CROWN DELTA CORP. TRYOUT-VPS HOLDING PASTE 05/17/2013
K902078 CRX MEDICAL, INC. ADD'L INDICATION FOR OCTYLDENT 2-OCTYL CRANOACRY. 08/03/1990
K884652 CRX MEDICAL, INC. OCTYLDENT 05/24/1989
K821326 CUTTER LABORATORIES, INC. CUTTER BOND POLYCARBOXYLATE CEMENT 05/28/1982
K813532 CUTTER LABORATORIES, INC. CUTTERBOND ZINC PHOSPHATE CEMENT 03/02/1982
K881918 DEN-MAT CORP. LIGHT-CURED ZIONOMER CEMENT 07/15/1988
K852196 DEN-MAT CORP. ZIONOMER CEMENT 06/20/1985
K073101 DENALI CORPORATION AURAVENEER CEMENT 01/17/2008
K132393 DENALI CORPORATION CERCOM II CEMENT 03/14/2014
K141503 DENALI CORPORATION DENALI 501CEMENT 11/10/2014
K083398 DENALI R&D CORPORATION CERCOM CEMENT 01/26/2009
K791160 DENPAC CORP. DENTALEEN 02/21/1980
K830440 DENTA, INC. DENTA PLAST 04/28/1983
K942665 DENTAURAUM, INC. ORTHOCENT: LIQUID AND POWDER 07/22/1994
K101493 DENTSPLY INTERNATIONAL, INC. ADVANCED GLASS IONOMER (K-130) RESTORATIVE 08/19/2010
K073173 DENTSPLY INTERNTIONAL SELF-ADHESIVE RESIN CEMENT 01/23/2008
K974140 DENTSPLY INTL. ADHESIVE HYBRID IONOMER CEMENT 01/05/1998
K896340 DENTSPLY INTL. BIOMER(R) F COMPOSITE LUTING CEMENT 05/15/1990
K040906 DENTSPLY INTL. CALIBRA CEMENT 06/16/2004
K874945 DENTSPLY INTL. CEMENT LINER 02/19/1988
K812858 DENTSPLY INTL. CHEMFIL 12/31/1981
K901524 DENTSPLY INTL. CHEMFIL II CAPS 09/19/1990
K003921 DENTSPLY INTL. DYRACT CEM LCI COMPOMER 01/24/2001
K041272 DENTSPLY INTL. DYRACT CEM PLUS CEMENT 10/18/2004
K981965 DENTSPLY INTL. FLOWABLE COMPOSITE 07/10/1998
K040895 DENTSPLY INTL. INTEGRITY TEMPORARY CEMENT 05/21/2004
K864720 DENTSPLY INTL. LIGHT-CURED PERIODONTAL DRESSING 04/07/1987
K864725 DENTSPLY INTL. MODI. DICOR CASTABLE CERAMIC/ALL PORCELAIN BRIDGES 01/21/1987
K923473 DENTSPLY INTL. MULTIPURPOSE RESIN CEMENT 04/12/1993
K940459 DENTSPLY INTL. MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF) 04/29/1994
K940914 DENTSPLY INTL. NEW LUTING CEMENT MATERIAL (NLC) 08/29/1994
K895487 DENTSPLY INTL. TEMPORARY DENTAL CEMENT 04/02/1990
K931229 DENTSPLY INTL. VARIGLASS VLC GLASS IONOMER 07/08/1993
K923328 DENTSPLY INTL. VENEER CEMENT 09/09/1992
K913836 DENTSPLY INTL. VLC GLASS IONOMER 10/17/1991
K100247 DETAX GMBH & CO. KG DETAX IMPLANTLINK SEMI 07/23/2010
K123824 DFL INDUSTRIA E COMERCIO S.A. VITRO FIL LC 02/21/2013
K123826 DFL INDUSTRIA E COMERCIO S.A. VITRO MOLAR 02/14/2013
K991172 DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH IONOSIT BOND 05/17/1999
K012316 DMG USA, INC. PERMACEM / PERMACEM DUAL 08/23/2001
K093338 DMG USA, INC. SELF ADHESIVE COMPOSITE LUTING CEMENT 02/12/2010
K160443 DMG USA, INC. TempoCem Clear 09/30/2016
K023649 DMG USA, INC. VITIQUE SYSTEM 01/17/2003
K100510 DOXA AB CERAMIR CROWN & BRIDGE 03/25/2010
K113040 DOXA DENTAL AB CERAMIR CROWN & BRIDGE 12/28/2011
K081405 DOXA DENTAL AB XERACEM 08/21/2008
K973636 DR. HOWARD MARTIN, P.A. MCS-MEDICATED CANAL SEALER 07/27/1998
K883698 E&D DENTAL MANUFACTURING CO. ZINC OXIDE EUGENOL TEMPORARY CEMENT 11/29/1988
K002793 ESPE DENTAL AG KETAC CEM U 09/26/2000
K984248 ESPE DENTAL AG PROCEM 01/08/1999
K802819 ESPE DENTAL PRODUCTS KETAC-CEM IN REF. TO K802048 11/24/1980
K974458 ESPE DENTAL-MEDIZIN GMBH & CO.KG. COMPOLUTE APLICAP 02/02/1998
K963737 ESPE GMBH & CO. KG. HYCEM APLICAP 11/15/1996
K973262 ESPE GMBH & CO. KG. KETAC-FIL APLICAP PLUS 11/17/1997
K960954 ESPE GMBH & CO. KG. KETAC-MOLAR APLICAP 05/16/1996
K884475 ESPE GMBH (US) CHELON-FIL 12/05/1988
K844846 ESPE GMBH (US) ESPE KETAC-CEM RADIOPAQUE 03/25/1985
K770923 ESPE GMBH (US) ESPETEMP (TEMP. CEMENT) 06/01/1977
K790832 ESPE GMBH (US) KETAC APPLIC-CAPSULES 04/30/1979
K874788 ESPE GMBH (US) KETAC-BOND APLICAP 04/12/1988
K897188 ESPE GMBH (US) KETAC-CEM MAXICAP 03/27/1990
K872984 ESPE GMBH (US) KETAC-CONDITIONER 03/09/1988
K843566 ESPE GMBH (US) KETAC-SILVER 12/06/1984
K915005 ESPE GMBH (US) PHOTAC-BOND APLICAP, MODIFICATION 01/14/1992
K925027 ESPE GMBH (US) PHOTAC-FIL APLICAP 06/18/1993
K812115 ESPE-PREMIER SALES CO. KETAC-CHEM 08/31/1981
K152691 ESSENTIAL DENTAL SYSTEMS, INC EDS Universal Cement 02/25/2016
K922249 ESSENTIAL DENTAL SYSTEMS, INC. FLEXI-FLOW CEMENT NATURAL 01/26/1994
K922250 ESSENTIAL DENTAL SYSTEMS, INC. FLEXI-FLOW CEMENT WITH TITANIUM 01/26/1994
K101504 ESSENTIAL DENTAL SYSTEMS, INC. TI-CORE FLOW 10/29/2010
K142446 EXACTA DENTAL DIRECT, INC Fixtemp Cement 06/04/2015
K011520 FIRST SCIENTIFIC LIMITED RESTORE-X 07/23/2001
K864898 FOREMOST DENTAL MFG., INC. FOREMOST DENTIN ADHESIVE 02/12/1987
K871562 FOREMOST DENTAL MFG., INC. IONOCAL 05/20/1987
K970775 FOREMOST DENTAL MFG., INC. TEMPO CEM (MULTIPLE) 06/03/1997
K970774 FOREMOST DENTAL MFG., INC. TEMPOCEM NE (MULTIPLE) 06/03/1997
K812568 G-C INTL. CORP. "CAVITRON" 09/25/1981
K851468 G-C INTL. CORP. 76 EMA LINING CEMENT 05/01/1985
K880848 G-C INTL. CORP. FUJI CAP II CAPSULE & APPLIER 05/16/1988
K913884 G-C INTL. CORP. FUJI II LC 10/30/1991
K811521 G-C INTL. CORP. FUJI IONOMER TYPE I & II 06/26/1981
K896883 G-C INTL. CORP. GC CERVICAL CEMENT 07/06/1990
K883770 G-C INTL. CORP. RESUBMITTED EMA DENTIN CEMENT 11/30/1988
K152652 GAIA DENTAL PRODUCTS, INC. PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement 04/05/2016
K120243 GC AMERICA INC. GAM-200 06/27/2012
K172382 GC America Inc. GC Fuji Direct 04/02/2018
K091106 GC AMERICA, INC. EQUIA 06/17/2009
K946100 GC AMERICA, INC. FUJI DUET 01/20/1995
K980695 GC AMERICA, INC. FUJI I 04/13/1998
K980682 GC AMERICA, INC. FUJI II 04/03/1998
K961584 GC AMERICA, INC. FUJI II LC (IMPROVED) 05/24/1996
K951555 GC AMERICA, INC. FUJI IX 05/23/1995
K961448 GC AMERICA, INC. FUJI IX GP 07/08/1996
K013198 GC AMERICA, INC. FUJI VII CAPSULE 10/29/2001
K153231 GC AMERICA, INC. G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer 07/06/2016
K935521 GC AMERICA, INC. GC ELITE CEMENT 01/06/1994
K021038 GC AMERICA, INC. GC ELITE CEMENT 100 05/03/2002
K070319 GC AMERICA, INC. GC FUJI IX GP EXTRA 02/26/2007
K051427 GC AMERICA, INC. GC FUJI FIL LC 08/22/2005
K020117 GC AMERICA, INC. GC FUJI LINING LC PASTE PAK 02/28/2002
K101420 GC AMERICA, INC. GC FUJI TEMP 09/17/2010
K001730 GC AMERICA, INC. GC FUJICEM 07/17/2000
K073283 GC AMERICA, INC. GC GAM-100 02/20/2008
K061535 GC AMERICA, INC. GC XLC-100 CAPSULE 07/14/2006
K070840 GC AMERICA, INC. GVC-100 05/15/2007
K001823 GC AMERICA, INC. LINKMAX 08/16/2000
K981370 GC AMERICA, INC. MIRACLE MIX CAPSULE 06/01/1998
K984505 GC AMERICA, INC. MIRACLE MIX POWDER/LIQUID 02/04/1999
K023727 GC AMERICA, INC. TEMPORARY CEMENT-DC010002 01/16/2003
K023888 GLOBAL DENTAL PRODUCTS, INC. CIMOFLUOR 03/05/2003
K013446 GLUSTITCH, INC. GLUSITE, MODEL GLU002 12/20/2001
K071484 GLUSTITCH, INC. PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 10/10/2007
K911061 H.A. OPOTOW CONSULTING ESPE KETAC-ENDO APLICAP 01/03/1992
K050658 HAGER WORLDWIDE, INC. RESO-PAC PERIODONTAL DRESSING 05/27/2005
K983752 HARRY J. BOSWORTH CO. ALUMINA-ZINC OXIDE POWDERS F AND R 12/10/1998
K103585 HARRY J. BOSWORTH CO. BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP 03/04/2011
K874500 HARRY J. BOSWORTH CO. GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM. 02/18/1988
K981618 HARRY J. BOSWORTH CO. LIQUID A 07/28/1998
K030727 HEALEX PRODUCTS, INC. POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT 06/05/2003
K010541 HERAEUS KULZER, INC. PREVISION CHEM 07/31/2001
K842994 INT'L CORP. EMA FREEGENOL DENTAL CEMENT 10/18/1984
K842995 INT'L CORP. EMA LIV CENERA DENTAL CEMENT 10/30/1984
K122549 ITENA CLINICAL DENTO TEMP 04/26/2013
K122551 ITENA CLINICAL PROVITEMP 06/14/2013
K121804 ITENA CLINICAL PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM 04/19/2013
K162960 ITENA CLINICAL TotalC-Ram 03/14/2017
K902052 IVOCLAR NORTH AMERICA, INC. AHYDRON DENTAL CLEANING AGENT 07/13/1990
K981335 IVOCLAR NORTH AMERICA, INC. ARISTON PHC LINER 07/02/1998
K980922 IVOCLAR NORTH AMERICA, INC. PROTEC CEM. 04/30/1998
K950060 IVOCLAR NORTH AMERICA, INC. PROVILINK 02/10/1995
K973397 IVOCLAR NORTH AMERICA, INC. SYNTAC SPRINT 11/21/1997
K003407 IVOCLAR NORTH AMERICA, INC. SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) 01/26/2001
K950428 IVOCLAR NORTH AMERICA, INC. VIVAGLASS BASE 02/17/1995
K962297 IVOCLAR NORTH AMERICA, INC. VIVAGLASS CEM 06/26/1996
K961910 IVOCLAR NORTH AMERICA, INC. VIVAGLASS FIL 06/26/1996
K130436 IVOCLAR VIVADENT AG MULTILINK HYBRID ABUTMENT CEMENT 08/20/2013
K120432 IVOCLAR VIVADENT AG TELIO CS CEM IMPLANT 06/08/2012
K032470 IVOCLAR VIVADENT, INC. MULTILINK 11/05/2003
K061781 IVOCLAR VIVADENT, INC. MULTILINK SPRINT 09/05/2006
K091019 IVOCLAR VIVADENT, INC. SPEEDCEM 06/04/2009
K042847 IVOCLAR VIVADENT, INC. SYSTEMP.CEM 12/17/2004
K042846 IVOCLAR VIVADENT, INC. SYSTEMP.LINK 12/20/2004
K933459 J.L. BLOSSER, INC. RESIMENT WITH FLUORIDE 10/20/1993
K934073 JEDENTAL CO., INC. JEDENTAL GLASS IONOMER CEMENT AND LINER 01/26/1994
K933554 JEDENTAL CO., INC. JEDENTAL ZINC CEMENT IMPROVED 11/01/1993
K933612 JEDENTAL CO., INC. JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT) 02/24/1994
K933543 JEDENTAL CO., INC. ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT) 11/01/1993
K000173 JENERIC/PENTRON, INC. CEMENT IT! UNIVERSAL C&B 02/29/2000
K870211 JOHNSON & JOHNSON PROFESSIONALS, INC. BONDEX* GLASS IONOMER CEMENT 03/18/1987
K790127 JOHNSON & JOHNSON PROFESSIONALS, INC. CEMENT, CERAMCO 02/26/1979
K990155 KAY SEE DENTAL MFG. CO. HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010 02/25/1999
K062519 KERR CORPORATION NEXUS 3 10/19/2006
K123595 KERR CORPORATION NEXUS RMGI 02/19/2013
K880250 KERR CORPORATION (DANBURY) KERR "XR BOND" 06/01/1988
K880251 KERR CORPORATION (DANBURY) KERR "XR IONOMER" 06/01/1988
K880685 KERR CORPORATION (DANBURY) PORCELITE DUAL CURE CEMENT 05/11/1988
K894219 KERR CORPORATION (DANBURY) TEMP BOND NE 09/18/1989
K972844 KERR DENTAL MATERIALS CENTER TEMP BOND CLEAR 10/03/1997
K892453 KULZER, INC. KULZER GLAS-IONOMER CEMENT 12/04/1989
K910719 KULZER, INC. SILICOATER MD 04/29/1991
K002322 KURARAY AMERICA, INC. MODIFICATION TO PANAVIA F 09/18/2000
K983361 KURARAY AMERICA, INC. PANAVIA F 11/13/1998
K933030 KURARAY CO. PANAVIA 21 02/24/1994
K855211 KURARAY CO. PANAVIA EX, A DENTAL ADHESIVE 03/13/1986
K910424 KURARAY CO. TEETHMATE-F 04/03/1991
K980232 KURARAY COMPANY, LTD. CLEARFIL DC CEMENT 02/24/1998
K012735 KURARAY MEDICAL INC. CLEARFIL DC CEMENT 09/14/2001
K062410 KURARAY MEDICAL INC. CLEARFIL ESTHETIC CEMENT & DC BOND 09/26/2006
K081583 KURARAY MEDICAL INC. CLEARFIL SA CEMENT 07/28/2008
K012438 KURARAY MEDICAL INC. MODIFICATION TO PANAVIA 21 09/05/2001
K012441 KURARAY MEDICAL INC. PANAVIA F 09/06/2001
K032455 KURARAY MEDICAL INC. PANAVIA F 2.0 11/07/2003
K120379 KURARAY MEDICAL INC. PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S 03/30/2012
K120378 KURARAY MEDICAL INC. PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S 03/30/2012
K142625 KURARAY NORITAKE DENTAL INC. PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS) 01/27/2015
K142623 KURARAY NORITAKE DENTAL, INC. PANAVIA SA Cement Plus Handmix 02/26/2015
K150704 KURARAY NORITAKE DENTAL, INC. PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Pa 08/21/2015
K780301 L.D. CAULK CO. CAULK TYLOK 02/28/1978
K790586 L.D. CAULK CO. CHEMBOND 05/16/1979
K960910 LOCTITE CORP. INDERMIL DENTAL 03/28/1996
K874458 LUSTGARTEN MULTI-TECH INTERNATIONAL, INC. PRIME PLUS-POLYACRYLIC ACID BOND CONDITIONER 03/18/1988
K890623 MACROCHEM CORP. FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENT 04/17/1989
K890608 MACROCHEM CORP. FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENT 04/17/1989
K812532 MADRID USO, JR., D.D.S. TEMP-FILL 10/14/1981
K964773 MAJESTIC DRUG CO., INC. DENTEMP ONE STEP 02/21/1997
K982779 MEDENTAL INTL. MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1 09/30/1998
K980990 MEDENTAL INTL. POLYCARBOXYLATE CEMENT 07/31/1998
K983018 MEDENTAL INTL. ZINC PHOSPHATE CEMENT 10/22/1998
K902894 MEDICAL DEVICE INSPECTION CO., INC. POST CEMENT (DENTAL COMPOSITE) 08/01/1990
K904034 MEDICAL DEVICE INSPECTION CO., INC. TEMPORARY DENTAL CEMENT 12/27/1990
K993556 MEDLOGIC GLOBAL CORP. LIQUIBAND DENTAL 01/03/2000
K171449 Meta Biomed Co., Ltd Metacem 05/15/2018
K081913 META BIOMED CO., LTD. METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER 09/05/2008
K062355 MICERIUM S.P.A. ENA CEM 12/27/2006
K032175 MILTON HODOSH, M.D. DESENS-IONOMER 10/09/2003
K925207 MILTON HODOSH, M.D. GLASS IONOMER CEMENT 07/08/1993
K882417 MILTON HODOSH, M.D. POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT 02/13/1989
K895988 MILTON HODOSH, M.D. POTASSIUM NITRATE-ZINC OXIDE EUGENOL TEMP. DENTAL 03/07/1990
K915666 MION INTERNATIONAL CORP. AMALCODEN 03/25/1992
K926376 MION INTERNATIONAL CORP. MION 525 10/21/1994
K942808 MION INTERNATIONAL CORP. TYPE I GLASS IONOMER CEMENT 11/03/1994
K971642 NEO DENTAL CHEMICAL PRODUCTS CO., LTD. DENTALIS KEZ ENDODONITC SEALER 07/24/1997
K830117 NORTH PACIFIC DENTAL, INC. ENDOMET 03/01/1983
K830107 NORTH PACIFIC DENTAL, INC. SELFAST 02/18/1983
K830113 NORTH PACIFIC DENTAL, INC. SEPTOPACK 05/09/1983
K120283 NOVOCOL, INC. DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT 07/31/2012
K040343 NOVOCOL, INC. TEMP F 08/03/2004
K801236 OKI SHIKS USA LTD. REIGNING EPOXY RESIN CEMENT 07/08/1980
K760239 ORATEC DENTAL PRODUCTS CEMENT, ULTRA-BOND 07/26/1976
K083516 OROSCIENCE, INC. PERIOGENIX 02/20/2009
K913519 ORTHO SOURCE SUMO GLASS IONOMER CEMENT 11/19/1991
K900303 PARKELL CONNECT 04/12/1990
K881914 PARKELL COVER UP 07/15/1988
K960464 PARKELL, INC. C & B METABOND (MODIFICATION) 02/26/1996
K101044 PARKELL, INC. RETRIEVE IMPLANT CEMENT 06/10/2010
K073698 PARKELL, INC. SECURE 03/19/2008
K031212 PARKELL, INC. TEMPORARY RESIN CEMENT 07/11/2003
K990381 PARKELL, INC. TOTALBOND 05/17/1999
K770067 PARKER LABORATORIES, INC. CYANOBOND 01/25/1977
K800060 PARKER LABORATORIES, INC. PROVIT 01/23/1980
K060698 PENTRON CLINICAL TECHNOLOGIES CEMENT-IT ALL PURPOSE, MODEL N97 05/10/2006
K081887 PENTRON CLINICAL TECHNOLOGIES LUTE-IT II VENEER CEMENT, MODEL NO6 08/29/2008
K022150 PENTRON CLINICAL TECHNOLOGIES TRIONOMER 08/21/2002
K150601 Premier Dental Company Products Zeramic Adhesive Resin Cement 07/22/2015
K033309 PREMIER DENTAL PRODUCTS CO. PREMIER IMPLANT CEMENT, MODEL 3001450 01/26/2004
K051866 PREMIER DENTAL PRODUCTS CO. PREMIER TEMPORARY CEMENT 09/06/2005
K042215 PREMIER DENTAL PRODUCTS CO. RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT 09/21/2004
K771451 PREMIER DENTAL PRODUCTS CO. SCUTABOND 08/16/1977
K112574 PRIME DENTAL MANUFACTURING, INC. PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT 01/23/2012
K853091 PSP DENTAL CO., LTD. CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE 01/21/1986
K853090 PSP DENTAL CO., LTD. CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO 01/21/1986
K953301 PULPDENT CORP. DENTASTIC ONE-STEP 08/25/1995
K953272 PULPDENT CORP. PULPDENT DENTASTIC II 08/25/1995
K974014 PULPDENT CORP. PULPDENT DENTASTIC UNO 12/17/1997
K962747 PULPDENT CORP. PULPDENT ENDODONTIC POST CEMENT KIT 09/30/1996
K951270 PULPDENT CORP. PULPDENT GLASS IONOMER CEMENTS 05/31/1995
K972445 PULPDENT CORP. PULPDENT OX-OUT 10/02/1997
K946137 PULPDENT CORP. PULPDENT PERIODONTAL DRESSINGS 01/26/1995
K952960 PULPDENT CORP. PULPDENT POST CEMENT 07/19/1995
K955017 PULPDENT CORP. PULPDENT RESILUTE 12/01/1995
K962383 PULPDENT CORP. PULPDENT RESILUTE II 09/03/1996
K810545 PULPDENT CORP. OF AMERICA PCA PERIOCARE PERIODONTAL DRESSING 03/24/1981
K853447 PULPDENT CORP. OF AMERICA POLYCARB WATER SET 10/16/1985
K020481 PULPDENT CORPORATION PULPDENT POST CEMENT 04/17/2002
K040236 PULPDENT CORPORATION PULPDENT VLC RESIN CEMENT 04/20/2004
K130223 PULPDENT CORPORATION RMGI FILL 03/29/2013
K123265 PULPDENT CORPORATION RMGI LOW VISCOSITY 12/07/2012
K934405 RELIANCE ORTHODONTIC PRODUCTS, INC. PRECEDENT 01/21/1994
K010240 RITE-DENT MANUFACTURING CORP. POLYCARBOXYLATE (PCA) CEMENT 03/27/2001
K003427 RITE-DENT MANUFACTURING CORP. ZINC PHOSPHATE CEMENT 01/24/2001
K081702 S & C POLYMER GMBH CARBOXYLATE CEM, PHOSPHATE CEM 09/05/2008
K011064 S & C POLYMER GMBH CLASSIC CEM 05/17/2001
K091735 S & C POLYMER GMBH DC PROVI CEM ESTHETIC, ESTHETIC MULTI F, IMPLANT 09/25/2009
K083766 S & C POLYMER GMBH PHOGLASS CEM 03/02/2009
K082115 S & C POLYMER GMBH PHOGLASS FILL, CORE, CEM, SEAL, PRIME AND PHOGLASS PROTECT 01/15/2009
K973201 S & C POLYMER GMBH PROVI CEMENT 06/05/1998
K011431 S & C POLYMER GMBH RESIN CEM 06/11/2001
K972935 S.S. WHITE MFG., LTD. SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL 01/29/1998
K823935 SCI-PHARM, INC. MICRO JOIN, CROWN & BRIDGE ADHESIVE 02/07/1983
K870334 SCIENTIFIC PHARMACEUTICALS, INC. "BOSTON POST CEMENT" 02/19/1987
K993324 SCIENTIFIC PHARMACEUTICALS, INC. CARBOCEM ZINC POLYCARBOXYLATE CEMENT 11/09/1999
K904024 SCIENTIFIC PHARMACEUTICALS, INC. CEMPER 11/09/1990
K051952 SCIENTIFIC PHARMACEUTICALS, INC. EUGENONE 09/07/2005
K934184 SCIENTIFIC PHARMACEUTICALS, INC. FASTFIL 12/13/1993
K895386 SCIENTIFIC PHARMACEUTICALS, INC. GLASION 04/16/1990
K884081 SCIENTIFIC PHARMACEUTICALS, INC. INTERIM, TEMPORARY CEMENT 12/02/1988
K013555 SCIENTIFIC PHARMACEUTICALS, INC. SCI-PHARM POST SECURE 01/23/2002
K982913 SCIENTIFIC PHARMACEUTICALS, INC. ZINFOS ZINC PHOSPHATE CEMENT 10/19/1998
K073043 SDI LTD. SET PP 12/14/2007
K761354 SEPTODONT, INC. CIMPAT (PINK AND WHITE) 01/03/1977
K771114 SEPTODONT, INC. NEUTROCIM 01/04/1978
K761355 SEPTODONT, INC. SELFAST 01/03/1977
K160345 SHANDONG HUGE DENTAL MATERIAL CORPORATION Glass Ionomer Cement 03/03/2017
K161851 SHANDONG HUGE DENTAL MATERIAL CORPORATION Glass Ionomer Cement (Luting) 10/31/2016
K841195 SHOFU DENTAL CORP. GLAS IONOMER CEMENT 05/14/1984
K850913 SHOFU DENTAL CORP. GLAS IONOMER CEMENT 04/10/1985
K861005 SHOFU DENTAL CORP. GLASIONOMER BASE CEMENT 04/25/1986
K982461 SHOFU DENTAL CORP. GLASIONOMER CEMENT CX PLUS 08/24/1998
K031467 SHOFU DENTAL CORP. GLASIONOMER FX-II 07/17/2003
K971927 SHOFU DENTAL CORP. HI DENSE TC 06/30/1997
K945451 SHOFU DENTAL CORP. HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE 02/27/1995
K940122 SHOFU DENTAL CORP. HY BOND, GLASIONOMER CX 05/02/1994
K810764 SHOFU DENTAL CORP. HY-BOND POLYCARBOXYLATE CEMENT 06/12/1981
K002461 SHOFU DENTAL CORP. HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT 09/26/2000
K111855 SHOFU DENTAL CORP. HY-BOND RESIGLASS 11/17/2011
K841196 SHOFU DENTAL CORP. HY-BOND ZINC OXIDE EUGENOL TEMP. 05/11/1984
K810765 SHOFU DENTAL CORP. HY-BOND ZINC PHOSPHATE CEMENT 06/12/1981
K863141 SHOFU DENTAL CORP. KULZER GLASS IONOMER LINER 08/26/1986
K080517 SHOFU DENTAL CORP. RESICEM 06/11/2008
K862280 SHOFU DENTAL CORP. SHOFU LINING CEMENT 06/23/1986
K120159 SHOFU DENTAL CORPORATION BEAUTICEM SA 06/18/2012
K111685 SHOFU DENTAL CORPORATION IP TEMP CEMENT 09/02/2011
K112307 SHOFU DENTAL CORPORATION RESIGLASS PASTE 03/28/2012
K101869 SILMET LTD. PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) 09/29/2010
K062064 SOUTHERN DENTAL INDUSTRIES, INC. RIVA BOND LC 11/09/2006
K050870 SOUTHERN DENTAL INDUSTRIES, INC. RIVA LIGHT CURE 06/03/2005
K040393 SOUTHERN DENTAL INDUSTRIES, INC. RIVA LUTING 04/30/2004
K062065 SOUTHERN DENTAL INDUSTRIES, INC. RIVA LUTING PLUS 11/15/2006
K042452 SOUTHERN DENTAL INDUSTRIES, INC. RIVA SILVER 12/07/2004
K030516 SOUTHERN DENTAL INDUSTRIES, INC. RIVA-SELF CURE 04/17/2003
K051008 SOUTHERN DENTAL INDUSTRIES, LTD. SET 06/15/2005
K913572 SPECIALITES SEPTODONT AUTOPACK NON-EUGENOL PERIODONTAL DRESSING 10/09/1991
K885007 SPECIALITES SEPTODONT CIMPAT S "TEMPORARY DENTAL CEMENT" 03/01/1989
K915467 SPECIALITES SEPTODONT CIMPAT S DENTAL CEMENT 02/03/1992
K901082 SPECIALITES SEPTODONT CYANODONT DENTAL CEMENT 07/09/1990
K881661 SPECIALITES SEPTODONT IONOSCEM OR IONOSCELL GLASS IONOMER DENTAL CEMENT 06/07/1988
K881890 SPECIALITES SEPTODONT PROVISCEM OR PROVISCELL EUGENOL-FREE DENTAL CEMENT 07/15/1988
K982773 SPECIALITES SEPTODONT QUICKSET LIQUID AND POWDER 11/03/1998
K895798 SPECIALITES SEPTODONT SILCOT COPAL CAVITY VARNISH 12/21/1989
K134021 SPIDENT CO., LTD. ESTEMP IMPLANT, ESTEMP CLEAR 06/10/2014
K100290 SPIDENT CO., LTD. ESTEMP NE 02/17/2010
K781281 STAR DENTAL MFG. CO. CEMENT, DENTAL/CAVITY LINER 08/21/1978
K142130 STEINER LABORATORIES ORAL BOND 06/06/2016
K963078 STERI-OSS, INC. STERI-OSS TEMPORARY IMPLANT CEMENT 09/10/1996
K972965 STERI-OSS, INC. STERI-OSS UNTIL IMPLANT CEMENT 11/07/1997
K982400 STERI-OSS, INC. STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT 09/23/1998
K982895 STERNGOLD/IMPLAMED STERNOMEGA COMPOMER CEMENT 10/09/1998
K984340 STERNGOLD/IMPLAMED STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 01/08/1999
K002843 SULTAN CHEMISTS, INC. SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 11/15/2000
K823795 SYBRON CORP. EVERBOND GLASS IONOMER CEMENT 01/26/1983
K840407 SYBRON CORP. KERR RESIN BONDED BRIDGE CEMENT 05/21/1984
K151332 SYBRON DENTAL SPECIALTIES Nexus Universal, Nexus Universal Chroma 08/17/2015
K151526 SYBRON DENTAL SPECIALTIES Zone, ZoneFree, Zone A1 09/10/2015
K041474 SYBRON DENTAL SPECIALTIES, INC. MAXCEM 07/21/2004
K954762 SYBRON DENTAL SPECIALTIES, INC. NEXUS 11/02/1995
K992160 SYBRON DENTAL SPECIALTIES, INC. NEXUS 2 08/18/1999
K013609 SYBRON DENTAL SPECIALTIES, INC. NEXUS 2 CLEAR 01/16/2002
K013008 SYBRON DENTAL SPECIALTIES, INC. NEXUS 2 MODIFIED 10/02/2001
K955068 SYBRON DENTAL SPECIALTIES, INC. OPTIBOND 2A PRECOAT 12/11/1995
K945244 SYBRON DENTAL SPECIALTIES, INC. PULP CANAL SEALER EWT 12/29/1994
K944480 SYBRON DENTAL SPECIALTIES, INC. SEALAPEX 11/03/1994
K003658 SYBRON DENTAL SPECIALTIES, INC. TEMP-BOND NE 2 01/04/2001
K053565 SYBRON DENTAL SPECIALTIES, INC. TEMPBOND CLEAR WITH TRICLOSAN 02/03/2006
K982590 SYBRON DENTAL SPECIALTIES, INC. TEMPBOND CLEAR-2 10/08/1998
K954643 SYBRON DENTAL SPECIALTIES, INC. TRY-IN GEL 10/19/1995
K123273 TEMREX CORP. HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) 12/07/2012
K891607 THE IRISH SCENE DENTANURSE 08/11/1989
K011685 TOKUYAMA AMERICA, INC. BISTITE II DC 07/31/2001
K991711 TOKUYAMA AMERICA, INC. BISTITE II SC 07/07/1999
K011854 TOKUYAMA AMERICA, INC. TOKUYAMA M-BOND 09/04/2001
K150727 TOKUYAMA DENTAL CORPORATION ESTECEM 06/17/2015
K132255 ULTRADENT PRODUCTS INC. / ORATECH LLC ULTRACEM 10/24/2013
K111017 ULTRADENT PRODUCTS, INC. CLEARTEMP 06/06/2011
K941065 ULTRADENT PRODUCTS, INC. DEOX, OXYGEN BARRIER VISCOUS SOLUTION 06/16/1994
K060334 ULTRADENT PRODUCTS, INC. GI DENTSTAT 02/23/2006
K111836 ULTRADENT PRODUCTS, INC. PERMASHADE VENEER CEMENT 09/16/2011
K964808 ULTRADENT PRODUCTS, INC. SPETEMP 02/26/1997
K964809 ULTRADENT PRODUCTS, INC. SPETEMP EF 01/02/1997
K080768 ULTRADENT PRODUCTS, INC. ULTRATEMP FIRM, FAST AND REGULAR SET 04/11/2008
K994261 ULTRADENT PRODUCTS, INC. ULTRATEMP TEMPORARY POLYCARBOXYLATE CEMENT 02/02/2000
K962733 UNION BROACH, DIV. MOYCO INDUSTRIES, INC. CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920) 10/11/1996
K925713 VIDENT VITA CEREC DUO CEMENT 02/17/1993
K801229 VIVADENT (USA), INC. BONDALCAP (CARBOXYLATE) 06/04/1980
K801228 VIVADENT (USA), INC. BONDALCAP (SILICO-PHOSPHATE) 06/04/1980
K801227 VIVADENT (USA), INC. SILICAP 08/12/1980
K922853 VOCO GMBH AQUA IONOFIL 08/10/1992
K922854 VOCO GMBH AQUA MERON 08/05/1992
K926492 VOCO GMBH ARGION DENTAL CEMENT 04/08/1993
K926458 VOCO GMBH BIFIX DENTAL CEMENT 03/31/1993
K060894 VOCO GMBH BIFIX QM 05/02/2006
K083438 VOCO GMBH BIFIX SE 02/13/2009
K143212 VOCO GMBH Bifix Temp 05/01/2015
K930455 VOCO GMBH CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER 04/08/1993
K914073 VOCO GMBH F21(R) DENTAL CEMENT 10/21/1991
K912497 VOCO GMBH IONOBOND 07/30/1991
K033068 VOCO GMBH IONOFIL COLOR AC 10/31/2003
K042669 VOCO GMBH IONOFIL PLUS AC 10/20/2004
K915619 VOCO GMBH IONOFIL/LONOFIL MOLAR 02/25/1992
K090817 VOCO GMBH IONOLUX 07/23/2009
K140993 VOCO GMBH IONOSTAR MOLAR 10/20/2014
K160774 VOCO GMBH IonoStar Plus 08/03/2016
K930116 VOCO GMBH LCL 8 06/17/1993
K130421 VOCO GMBH MERON APPLICATION CAPSULES 08/14/2013
K914612 VOCO GMBH MERON DENTAL CEMENT 02/03/1992
K063554 VOCO GMBH MERON PLUS 01/12/2007
K180386 Voco GmbH Meron Plus QM 05/08/2018
K915618 VOCO GMBH PROVICOL 02/25/1992
K102612 VOCO GMBH VOCO IONOFIL MOLAR AC QUICK 11/19/2010
K935436 WALLACE A. ERICKSON & CO. ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED 06/10/1994
K955089 WALLACE A. ERICKSON & CO. ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT 12/13/1995
K942596 WALLACE A. ERICKSON & CO. ALPHA-LOCK OR PRO-LOCK FLUORIDE RELEASING GLASS IONOMER BAND CEMENT 06/16/1994
K790593 WALLACE A. ERICKSON & CO. DENTAL CEMENT, ZINC PHOSPHATE 06/15/1979
K771481 WELCH ALLYN, INC. TONGUE BLADE HOLDER 08/19/1977
K973370 WFR/AQUAPLAST CORP. AQUAPLAST PALATAL STENT 12/02/1997
K900342 WHALEDENT INTL. DIV. IPCO UNITY DENTAL CEMENT 05/07/1990
K030168 WIELAND DENTAL + TECHNIK GMBH & CO. KG AGC CEM 03/21/2003
K810026 WITECH LABORATORY DENTAL ENDODONTIC CEMENT 01/28/1981


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