FDA 510(k) Applications for Medical Device Product Code "ELW"
(Material, Impression)

FDA 510(k) Number Applicant Device Name Decision Date
K981325 3M COMPANY 3M M.G. MATERIAL 06/11/1998
K963766 3M COMPANY 3M PROPLUS SYSTEM 10/31/1996
K932459 3M COMPANY FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL 08/09/1993
K882690 3M COMPANY IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL 08/11/1988
K800485 3M COMPANY VINYL POLYSILOXANE IMPRESSION MATERIAL 03/18/1980
K120438 3M DEUTSCHLAND GMBH FLASH (DIFFERENT MATERIALS) 05/02/2012
K131404 3M DEUTSCHLAND GMBH FLASH AR PENTA / FLASH AR PENTA QUICK 05/30/2013
K133436 3M DEUTSCHLAND GMBH FLASH AR; FLASH AR QUICK 03/07/2014
K173318 3M Deutschland GmbH Rapid HB, Rapid LB, Rapid MB 10/31/2017
K133400 3M ESPE AG FLASH BITE 03/06/2014
K140602 3M ESPE AG FLASH PENTA MB QUICK, FLASH MB QUICK 06/05/2014
K051797 3M ESPE AG DENTAL PRODUCTS FUTURE WASH/YPS 07/21/2005
K080514 3M ESPE AG DENTAL PRODUCTS PECD-01 AND PECD QUICK-01 03/26/2008
K032001 3M ESPE AG DENTAL PRODUCTS POLY Q (GARANT L, PENTA M, PENTA H) 08/11/2003
K760981 ADP INTL., INC. ALGINATE IMPRESSION MATERIAL 11/15/1976
K954223 AMERICAN DENTAL PRODUCTS, INC. AMERICAN DENTAL PRODUCTS ALGINATE FLAVORING 09/29/1995
K800393 AMERICAN DENTAL RESEARCH POLY SULFIDE IMPRESSION PASTE W/CATALYST 04/10/1980
K963205 AMERICAN TOOTH INDUSTRIES ALGINMAX, ORTHOCHROME 10/29/1996
K113263 ARGES IMAGING, INC ARGES IMAGING CONTRAST SPRAY 11/14/2011
K860911 AUSTENAL DENTAL, INC. AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL 03/26/1986
K820061 BELPORT CO., INC. REVERSIBLE HYDROCOLLOID IMPRESSION MAT 02/22/1982
K072577 BISICO GMBH & CO KG BISICO IMPRESSION SILICONES & ALGINATES 12/05/2007
K131510 BLACKWELL DEVICE CONSULTING POLYDIMETHYLSILOXANE IMPRESSION MATERIAL 12/20/2013
K802990 BUFFALO DENTAL MFG. CO., INC. ALGINATE/SILICONE CROWN & BRIDGE MATER 02/02/1981
K802882 BUFFALO DENTAL MFG. CO., INC. HYDROCOLLOID COMPATIBLE CREAM ALGINATE 01/28/1981
K841490 BUFFALO DENTAL MFG. CO., INC. POLYSULFIDE CUSTOM TRAY MATERIAL 06/27/1984
K820216 BUFFALO DENTAL MFG. CO., INC. ULTRA-WET 02/24/1982
K820489 BUFFALO DENTAL MFG. CO., INC. ULTRAFINE TRAY ADHESIVE 03/19/1982
K102739 CASCADES DEVICE CONSULTING ASSOCIATES HYDROCOLOR 5 12/08/2010
K141092 CAVEX HOLLAND B.V MARK3 12/04/2014
K981970 CAVEX HOLLAND B.V. ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXI 09/02/1998
K011419 CAVEX HOLLAND B.V. CAVEX COLORCHANGE 07/16/2001
K051207 CAVEX HOLLAND B.V. CAVEX ORTHOTRACE 06/21/2005
K011452 CAVEX HOLLAND B.V. CAVEX STABISIL 07/19/2001
K072245 CAVEX HOLLAND B.V. EMULATE ADVANCED 11/08/2007
K020242 CAVEX HOLLAND B.V. EMULATE FAST SET AND EMULATE REGULAR SET 04/17/2002
K052455 CAVEX HOLLAND B.V. IMPRESSIX 11/23/2005
K062400 CAVEX HOLLAND B.V. IMPRESSIX, COLORCHANGE ALGINATE 11/16/2006
K000686 CAVEX HOLLAND B.V. KROM-ALGINATE AND ALGINATE PLUS 05/25/2000
K061267 CAVEX HOLLAND B.V. SIMULATE, COLOR CHANGE ALGINATE 07/10/2006
K980965 CAVEX HOLLAND B.V. SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL 05/01/1998
K023466 CAVEX HOLLAND B.V. TULIP ALGINATE IMPRESSION MATERIAL 12/13/2002
K032116 CAVEX HOLLAND B.V. TULIP COLORSWITCH 09/30/2003
K013336 CAVEX HOLLAND B.V. XANTALGIN CRONO 10/29/2001
K151535 CAVEX HOLLAND BV Cavex Cream Alginate 10/28/2015
K935151 CENTRIX, INC. HYDROCOLLOID HEATING UNIT 04/04/1994
K152826 CENTRIX, INC. NoCord 05/27/2016
K952728 CENTRIX, INC. RETRAC 09/29/1995
K053014 CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. POLY SILOXANE IMPRESSION MATERIAL 11/15/2005
K081017 CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. TEMPLATE AND COUNTER-FIT 08/04/2008
K842877 COE LABORATORIES, INC. ABSOLUTE VINYL POLYSILOXANE IMPRESS 03/11/1985
K903292 COE LABORATORIES, INC. ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS 10/19/1990
K894282 COE LABORATORIES, INC. FIRST IMPRESSION TM 12/22/1989
K894281 COE LABORATORIES, INC. FIRST IMPRESSION WITH CHLORHEXIDINE 09/26/1989
K881091 COE LABORATORIES, INC. OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL 06/28/1988
K760226 COE LABORATORIES, INC. PASTE, ACCOE IMPRESSION 07/21/1976
K760225 COE LABORATORIES, INC. PUTTY, ACCOE 07/21/1976
K811666 COLTENE, INC. COLTENE COLTEX/COLTOFLAX 07/15/1981
K850036 COLTENE, INC. COLTENE PRECISE 02/08/1985
K811767 COLTENE, INC. COLTENE PRESIDENT IMPRESSION MATERIALS 07/15/1981
K882800 COLTENE, INC. COLTENE PRESIDENT JET REGULAR BODY 09/23/1988
K811667 COLTENE, INC. COLTENE PRESSURE SPOT INDICATOR 07/15/1981
K870047 COLTENE, INC. COLTENE RAPID 01/29/1987
K051243 COLTENE/WHALEDENT AG JET BLUE BITE 06/23/2005
K050013 COLTENE/WHALEDENT AG RETRACTOFOAM 02/09/2005
K912485 COLTENE/WHALEDENT INC. COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC 07/25/1991
K830083 COLUMBUS DENTAL MFG. CO. SHUR GEL 02/07/1983
K860855 COLUMBUS DENTAL MFG. CO. SHUR GEL 4 06/16/1986
K952930 CONFI-DENTAL PRODUCTS CO. DENTRAY II PLUS TRAY ADHESIVE 09/08/1995
K936070 CONFI-DENTAL PRODUCTS CO. TREND SET 2 PLUS 02/04/1994
K073475 CONTINENTAL DENTAL LABORATORY SYSTEM PLUS 03/10/2008
K870011 CONTRACAP CONTRASYL IMPRESSION MATERIAL 03/19/1987
K041229 COSMEDENT, INC. MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) 06/17/2004
K896786 CRAFT DENTAL LABORATORY, INC. ZONAREX FINAL IMPRESSION COMPOUND 04/19/1990
K896785 CRAFT DENTAL LABORATORY, INC. ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/ 04/19/1990
K041028 CROWN DELTA CORP. CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL 05/14/2004
K801380 CROWN DELTA CORP. CROWN DELTA SILICONE IMPRESSION MATERIAL 07/08/1980
K821221 CROWN DELTA CORP. DENTAL IMPRESSION MATERIAL 06/07/1982
K781083 CROWN DELTA CORP. DENTAL SILICONE IMPRESSION MATERIAL 08/31/1978
K760231 CROWN DELTA CORP. IMPRESSION MATERIAL, DENTAL SILICON RTV 07/21/1976
K780778 CROWN DELTA CORP. RTV SILICONE HAND KNEADABLE PUTTY 05/31/1978
K843145 CROWN DELTA CORP. TWO COMPONENT RTV VINYL SILICONE MATER 10/18/1984
K930248 CROWN DELTA CORP. VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM 01/07/1994
K871409 CROWN DELTA CORP. VINYL POLYSILOXANE IMPRESSION SYSTEM 06/11/1987
K872745 CROWN DELTA CORP. VINYL POLYSILOXANE IMPRESSION SYSTEM 07/21/1987
K854106 CUTTER LABORATORIES, INC. BAYSILEX 03/17/1986
K760752 CUTTER LABORATORIES, INC. CUTTER FLEX-SILICONE IMPRESSION MAT. 10/15/1976
K760753 CUTTER LABORATORIES, INC. CUTTER JEL-ALGINATE IMPRESSION MAT. 10/20/1976
K760755 CUTTER LABORATORIES, INC. CUTTER SIL-SILICONE IMPRESSION MAT 10/15/1976
K842324 CUTTER LABORATORIES, INC. PERFOURM 11/09/1984
K152349 DANVILLE MATERIALS LLC Star+ VPS Scannable Impression Material 11/23/2015
K092319 DANVILLE MATERIALS, INC. STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 09/16/2009
K901866 DEGUSSA AG DEGUFLEX (R) CS LIGHT 09/07/1990
K901867 DEGUSSA AG DEGUFLEX (R) CS PUTTY 09/06/1990
K901865 DEGUSSA AG DEGUFLEX MONOPHASE 09/06/1990
K955465 DEGUSSA CORP. DEGUPRINT 12/28/1995
K983106 DEN-MAT CORP. 1ST IMPRESSION 02/09/1999
K810825 DENTAL-MATERIAL GESELLSCHAFT POLYVINYL SILICONE IMPRESSION MATERIAL 04/14/1981
K942666 DENTAURAUM, INC. ORTHALGENAT IMPRESSION MATERIAL 08/10/1994
K152766 DENTKIST, INC CharmFlex 03/08/2016
K152861 DENTPLY INTERNATIONAL INC. Aquasil Ultra + Smart Wetting Impression Material 03/04/2016
K113406 DENTSPLY INTERNATIONAL, INC. AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL 02/13/2012
K802362 DENTSPLY INTL. ALGINATE IMPRESSION MATERIAL 10/10/1980
K973781 DENTSPLY INTL. AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL 12/11/1997
K970433 DENTSPLY INTL. AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL 03/27/1997
K021416 DENTSPLY INTL. AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL 05/13/2002
K021413 DENTSPLY INTL. AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL 05/10/2002
K021410 DENTSPLY INTL. AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL 05/08/2002
K973782 DENTSPLY INTL. AQUASIL XLV SMART WETTING IMPRESSION MATERIAL 12/04/1997
K801587 DENTSPLY INTL. ASH BLUEPRINT ALGINATE IMPRESSION MATER. 07/21/1980
K943574 DENTSPLY INTL. CAPTURE IMPRESSION MATERIAL 08/23/1994
K883842 DENTSPLY INTL. DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI. 03/17/1989
K884166 DENTSPLY INTL. DICOR CERAMIC INLAY - NEW TECHNIC 04/17/1989
K952614 DENTSPLY INTL. JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL 08/13/1996
K862879 DENTSPLY INTL. NEW LIGHT-CURING IMPRESSION MATERIAL 09/25/1986
K860146 DENTSPLY INTL. POLYJEL N.F. (NEW FORMULA) 03/17/1986
K061427 DENTSPLY INTL. PRE-IMPRESSION CONDITIONING SOLUTION 06/26/2006
K940685 DENTSPLY INTL. PRETREATMENT SOLUTION 04/28/1994
K781151 DENTSPLY INTL. REPROSIL 08/31/1978
K040053 DISCUS DENTAL INC. PRECISION VPS IMPRESSION MATERIAL 03/25/2004
K052090 DISCUS DENTAL INC. SPLASH! IMPRESSION MATERIAL DEVICE 08/05/2005
K030776 DISCUS DENTAL, INC. MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL 05/09/2003
K000878 DMG USA, INC. HONIGUM 04/11/2000
K013236 DMG USA, INC. LUXABITE 10/17/2001
K013237 DMG USA, INC. STATUSBLUE 10/22/2001
K102836 DMP LTD BONASIL A+ IMPRESSION MATERIALS 01/13/2011
K171562 Dreve Dentamid GmbH Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono 04/13/2018
K991008 ESPE DENTAL AG DIMENSION BITE 06/18/1999
K000588 ESPE DENTAL AG DIMENSION GARANT L, DIMENSION GARANT L QUICK 03/30/2000
K000591 ESPE DENTAL AG DIMENSION PENTA H, DIMENSION PENTA H QUICK 03/30/2000
K000595 ESPE DENTAL AG DIMENSION PENTA L 04/05/2000
K992895 ESPE DENTAL AG IMPREGUM F 09/08/1999
K994190 ESPE DENTAL AG IMPREGUM GARANT L DUOSOFT 01/27/2000
K992897 ESPE DENTAL AG IMPREGUM PENTA 09/08/1999
K994193 ESPE DENTAL AG IMPREGUM PENTA DUOSOFT 01/28/2000
K994192 ESPE DENTAL AG IMPREGUM PENTA M MONOSOFT 01/28/2000
K991221 ESPE DENTAL AG VESTOGUM 05/20/1999
K800031 ESPE DENTAL PRODUCTS PERMADYNE POLYETHER RUBBER IMPRESSION 02/05/1980
K960547 ESPE GMBH & CO. KG. DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE 03/15/1996
K954192 ESPE GMBH & CO. KG. IMPREGUM PENTA 12/01/1995
K954180 ESPE GMBH & CO. KG. MICROGLISS 11/21/1995
K953374 ESPE GMBH & CO. KG. PERMADYNE GARANT 2:1 08/18/1995
K953027 ESPE GMBH & CO. KG. PERMADYNE PENTA (HIGH & LOW VISCOSITY) 07/19/1995
K974231 ESPE GMBH & CO. KG. POSITION PENTA, POSITION PENTA QUICK 01/29/1998
K952693 ESPE GMBH & CO. KG. RAMITEC PENTA 08/18/1995
K853529 ESPE GMBH (US) IMPREGUM-F 03/17/1986
K884381 ESPE GMBH (US) PALGAFLEX AND PALGAFLEX-QUICK 01/04/1989
K892839 ESPE GMBH (US) PALGARAPID 10/27/1989
K896539 ESPE GMBH (US) PERMADYNE GARANT LOW VISCOSITY 02/09/1990
K771627 ESPE GMBH (US) PERMAGUM 09/02/1977
K771853 ESPE GMBH (US) PERMAGUM ADHESIVE 10/13/1977
K892412 ESPE GMBH (US) POLYETHER-RETARDER 12/04/1989
K943475 ESSENTIAL DENTAL SYSTEMS, INC. ULTRA HYDROPHILIC ALGINAE 08/12/1994
K053427 EXACTA DENTAL PRODUCTS, INC. FRESH, DENTAL IMPRESSION MATERIAL 01/13/2006
K964323 FEN DENTAL MFG., INC. CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL 12/16/1996
K980963 FOREMOST DENTAL MFG., INC. HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES) 05/11/1998
K851469 G-C INTL. CORP. 76 ELW BITE CHECKER SILICONE 05/01/1985
K812406 G-C INTL. CORP. EXAFLEX IMPRESSION MATERIAL 10/06/1981
K812679 G-C INTL. CORP. G-C FIT-CHECKER IMPRESSION MATERIAL 10/06/1981
K844329 G-C INTL. CORP. SURFLEX F 12/03/1984
K181011 GC America Inc. AIM2 07/12/2018
K994077 GC AMERICA, INC. AROMA FINE (NORMAL AND FAST SET) 01/27/2000
K933206 GC AMERICA, INC. EXA BITE REGISTRATION MATERIAL 09/29/1993
K955932 GC AMERICA, INC. EXAFLEX IMPRESSION MATERIAL (MODIFICATION) 03/11/1996
K023751 GC AMERICA, INC. EXAJET 01/22/2003
K110871 GC AMERICA, INC. FIT CHECKER ADVANCED 06/17/2011
K032289 GC AMERICA, INC. FIT CHECKER II 10/20/2003
K043471 GC AMERICA, INC. FUSION FAST 01/27/2005
K043493 GC AMERICA, INC. FUSION PUTTY TYPE 03/04/2005
K120521 GC AMERICA, INC. GC BLUE SILICONE 05/10/2012
K041398 GC AMERICA, INC. GC FUSION 06/25/2004
K943388 GC AMERICA, INC. GC SURFLEX F 09/12/1994
K970656 GC AMERICA, INC. HYDROFLEX 04/08/1997
K973343 GC AMERICA, INC. HYDROFLEX 10/21/1997
K022430 GC AMERICA, INC. ISO FUNCTIONAL 10/18/2002
K042860 HANDAE CHEMICAL CO., LTD. CORRECT DENTAL IMPRESSION MATERIAL 12/03/2004
K994027 HARRY J. BOSWORTH CO. ACTIVATOR PASTE 04/13/2000
K991489 HARRY J. BOSWORTH CO. ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET) 07/15/1999
K991490 HARRY J. BOSWORTH CO. ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET) 07/15/1999
K031439 HARRY J. BOSWORTH CO. ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR) 10/02/2003
K960063 HARRY J. BOSWORTH CO. BOSWORTH IMPRESSION MATERIAL I 02/14/1996
K961201 HARRY J. BOSWORTH CO. BOSWORTH IMPRESSION MATERIAL II 05/17/1996
K991631 HARRY J. BOSWORTH CO. FASTRAY LC 07/26/1999
K940402 HARRY J. BOSWORTH CO. SUPERGEL/SUPPRESSED DUST 03/28/1994
K800548 HARRY J. BOSWORTH CO. SUPERSIL 03/18/1980
K926033 HARRY J. BOSWORTH CO. VINYL POLYSILOXANE IMPRESSION SYSTEM AND RE'CORD 05/05/1993
K951237 HEALTH-DENT INTL., INC. ALGI-BAND 04/10/1995
K904927 HENNSON INTL., INC. HENNSON INTERNATIONAL DENTAL CAD/CAM SYSTEM 12/28/1990
K080338 HERAEUS KULZER GMBH CUTTERSIL ACTIVATOR UNIVERSAL PLUS 04/21/2008
K965163 HERAEUS KULZER, INC. CUTTERSIL COMFORT 03/19/1997
K965165 HERAEUS KULZER, INC. CUTTERSIL COMFORT HARDENER 03/19/1997
K910360 HERAEUS KULZER, INC. CUTTERSIL FUNCTION ACTIVATOR 06/06/1991
K910165 HERAEUS KULZER, INC. CUTTERSIL MUCOSA 06/06/1991
K910166 HERAEUS KULZER, INC. CUTTERSIL XL 06/06/1991
K091494 HERAEUS KULZER, INC. FLEXITIME FLOW 07/31/2009
K042878 HERAEUS KULZER, INC. FLEXITIME XTREME 12/17/2004
K000629 HERAEUS KULZER, INC. FLEXTIME 04/05/2000
K003930 HERAEUS KULZER, INC. FLEXTIME MAGNUM 360 02/01/2001
K971155 HERAEUS KULZER, INC. MEMOREG 05/22/1997
K913537 HERAEUS KULZER, INC. MEMOSIL C.D. 10/04/1991
K030318 HERAEUS KULZER, INC. P2 POLYETHER 04/03/2003
K910189 HERAEUS KULZER, INC. PERFOURM PUTTY SOFT 06/06/1991
K973694 HERAEUS KULZER, INC. PROVIL NOVO 11/24/1997
K991425 HERAEUS KULZER, INC. XANTOPREN COMFORT 06/15/1999
K082591 HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION FLEXITIME BITE 12/05/2008
K120914 HERAEUS KULZER, LLC FLEXITIME FAST & SCAN LIGHT FLOW 07/25/2012
K113574 HERAEUS KULZER, LLC FLEXITIME MONOPHASE PRO SCAN 07/13/2012
K101617 HERAEUS KULZER, LLC FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL 09/07/2010
K102770 HERAEUS KULZER, LLC FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW 12/21/2010
K130647 HERAEUS KULZER, LLC XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML 05/17/2013
K132869 HRS CO., LTD. SILDENT 06/19/2014
K181604 HRS Co., Ltd. Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite 11/28/2018
K140074 HYGEDENT INC HYGEDENT ALGINATE IMPRESSION MATERIAL 05/21/2014
K170812 HYGEDENT INC. HygePLUS Alginate Impression Material 07/26/2017
K962680 HYUNJAE CORP. HYUNJAE DENTAL IMPRESSION MATERIALS 09/30/1996
K771248 INTERSTATE DENTAL CO., INC. SILICONE IMPRESSION MATEOIAL 07/15/1977
K103586 IOS TECHNNOLOGIES, INC. IOS FASTSCAN SPRAY 03/30/2011
K896468 IVOCLAR NORTH AMERICA, INC. EOS BLUEPHASE-P AND REDPHASE-P IMPRESSION MATERIAL 04/30/1990
K143575 IVOCLAR VIVADENT, INC. Accu-Dent XD Tray, Accu-Dent XD Syringe 04/03/2015
K060891 IVOCLAR VIVADENT, INC. VIRTUAL 07/17/2006
K811867 J. ADERER, INC. SR-ALGICAP 10/02/1981
K810523 J. ADERER, INC. SR-IVOSEAL 04/14/1981
K964692 J. MORITA USA, INC. PERFECTIM 02/25/1997
K001218 JENERIC/PENTRON, INC. CORRECT PLUS 07/05/2000
K914437 JENERIC/PENTRON, INC. CORRECT-S.I.M. 01/17/1992
K914178 JENERIC/PENTRON, INC. CORRECTED-V.P.S. 04/28/1992
K923202 JENERIC/PENTRON, INC. Q3 (LIGHT AND UNIVERSAL) IMPRESSION MATERIAL 08/27/1992
K001655 KERR CORP. PERMLASTIC 2 08/10/2000
K031484 KERR CORP. STAND OUT 07/03/2003
K072622 KERR CORP. STANDOUT 2 12/04/2007
K091613 KERR CORP. TAKE 1 10/07/2009
K010994 KERR CORP. TAKE ONE BITE MODIFIED 04/23/2001
K160441 KERR CORPORATION Identic and KromaFaze Alginate Dental Impression Materials 06/30/2016
K110092 KERR CORPORATION TAKE 1 ADVANCED RIGID TRAY 04/08/2011
K092176 KERR CORPORATION TAKE 1 ADVANCED RIGID TRAY 01/28/2010
K860532 KERR CORPORATION (DANBURY) KERR POL-E-LASTIC DENTAL IMPRESSION MATERIAL 03/20/1986
K781689 KERR CORPORATION (DANBURY) REFLECT IMPRESSION MATERIAL 11/15/1978
K904482 KERR CORPORATION (DANBURY) STAT.BR TM 11/29/1990
K081120 KETTENBACH GMBH & CO KG FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS 05/01/2008
K113279 KETTENBACH GMBH & CO KG IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT 11/14/2011
K092867 KETTENBACH GMBH & CO KG IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT 10/01/2009
K082157 KETTENBACH GMBH & CO KG KETTOSIL AND SILGINAT 08/06/2008
K082560 KETTENBACH GMBH & CO KG PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT 09/08/2008
K083701 KETTENBACH GMBH & CO KG PANASIL INITIAL CONTACT AND PANASIL TRAY 01/09/2009
K811020 KOTTLER LABORATORIES REVERSIBLE HYDROCOLLOID IMPRESSION 05/05/1981
K901681 KULZER, INC. FORMASIL(R)A POLYVINYL SILOXANE LINE 06/15/1990
K071192 LANCER ORTHODONTICS, INC. BLUGOO HD 06/22/2007
K121824 LASCOD SPA ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 08/23/2012
K980968 LONE STAR TECHNOLOGIES LONE STAR IMPRESSION SYSTEMS 06/09/1998
K011785 MANUFACTURERA DENTAL CONTINENTAL NOVEL PRINT CYAN ALGINATES 09/04/2001
K974894 MATECH, INC. KROMATICA COLOR CHANGING ALGINATE 02/12/1998
K925746 MATECH, INC. REPLICA 01/21/1994
K134008 META BIOMED, INC. MD-FLEX HEAVY BODY 04/09/2014
K132599 MILLENNIUM COMPANY LLC SMILEBOND SYSTEM 02/25/2014
K053018 MILLENNIUM DENTAL INTERNATIONAL, INC. POLY SILOXANE IMPRESSION MATERIAL 11/08/2005
K810839 MOYCO INDUSTRIES, INC. SPOTAR 04/29/1981
K152180 Neosil Co., Ltd PEAK 10/22/2015
K180565 Neosil Co., Ltd PEAK NS033CF, PEAK NS017CF 06/13/2018
K964177 NORTH AMERICAN ORTHODONTIC LABORATORIES, INC. KROMALGIN IMPRESSION MATERIAL 12/30/1996
K011450 NORTHEAST RESINS & SILICONES, LLC. SILICONE IMPRESSION MATERIAL 06/13/2001
K760238 ORATEC DENTAL PRODUCTS IMPRESSION MATERIAL, TRIFLEX SILICONE 07/26/1976
K760240 ORATEC DENTAL PRODUCTS IMPRESSION MATERIAL, TRIFLEX SILICONE 07/26/1976
K133527 OSSTEM GERMANY GMBH SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT 03/07/2014
K181236 OSSTEM IMPLANT CO LTD HySil Impression Materials 09/13/2018
K151262 Osstem Implant Co., Ltd Hyflex Heavy, Hyflex Mono, Hyflex Light 09/21/2015
K170736 Osstem Implant Co., Ltd.. HySil Impression Materials 06/07/2017
K151150 PAC-DENT INTERNATIONAL, INC. Elements 07/28/2015
K972871 PACIFIC RIM DENTAL, INC. GENESIS 10/02/1997
K855112 PACIFIC UNION DENTAL, INC. DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYS 03/06/1986
K855111 PACIFIC UNION DENTAL, INC. DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES 03/06/1986
K905032 PARKELL MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL 03/15/1991
K792363 PARKELL, INC. SILAGUM 01/09/1980
K962741 PARKELL, INC. TRI-PHASIX CHROMATIC ALGINATE 09/06/1996
K950299 PELTON & CRANE CO. CEREC 2 05/23/1995
K130920 PENTRON CLINICAL CORRECT PLUS 1 07/02/2013
K120013 PENTRON CLINICAL TEMPSPAN CLEAR MATRIX 05/22/2012
K925370 PILLING CO. TRIANGULAR JAW MICROLARYNGEAL FORCEPS 03/18/1993
K782139 PREMIER DENTAL PRODUCTS CO. ZYLOX 02/21/1979
K853089 PSP DENTAL CO., LTD. SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE 04/21/1986
K844446 PULPDENT CORP. OF AMERICA BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC. 10/29/1985
K001414 R-DENTAL DENTALERZEUGNISSE GMBH KWIKKMODEL 08/09/2000
K010926 R-DENTAL DENTALERZEUGNISSE GMBH R-SI-LINE METAL-BITE 04/12/2001
K892935 RESOUND CORP. RESOUND IMPRESSION MATERIAL 07/14/1989
K013859 RHODIA INC. RHODIA BITE REGISTRATION MATERIAL 01/29/2002
K013129 RHODIA INC. RHODIA DENTAL PUTTY IMPRESSION MATERIAL 10/10/2001
K013140 RHODIA INC. RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL 10/10/2001
K970129 RICHARD TING TULIP 08/18/1997
K003426 RITE-DENT MANUFACTURING CORP. ALGINATE IMPRESSION MATERIAL 01/23/2001
K133071 RIZHAO HUGE DENTAL INDUSTRY CO., LTD ELASTIC IMPRESSION MATERIAL 05/28/2014
K942219 ROBERT W. BAUER & ASSOC., INC. ALGIDENCO AND ALGIPRINT IMPRESSION MATERIALS 08/12/1994
K954281 ROYDENT DENTAL PRODUCTS, INC. PANASIL IMPRESSION MATERIAL 06/24/1996
K012767 S & C POLYMER GMBH S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL 11/01/2001
K951075 S & C POLYMER GMBH S & C VINYL POLYSILOXANE IMPRESSION MATERIAL 03/31/1995
K965083 S.S. WHITE MFG., LTD. SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET 04/04/1997
K945142 SCICAN POLYSIL (VINYL POLYSILOXAN IMPRESSION MATERIAL) 01/11/1995
K143382 SeilGlobal Co., Ltd. DentiAnn Smart Sil 02/23/2015
K032708 SEPTODONT PLASTALGIN AND PLASTALGIN ORTHO 11/20/2003
K103346 SHERPA KOREA DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY 02/11/2011
K972276 SIEMENS AG CEREC 2 CROWN SOFTWARE 08/15/1997
K992001 SILICON-UND COMPOSITE SPEZIALITATEN GMBH TRAY-LINK 11/02/1999
K994172 SIRONA DENTAL SYSTEMS GMBH CEREC 3 02/08/2000
K080882 SIRONA DENTAL SYSTEMS GMBH CEREC OPTI SPRAY 04/11/2008
K012517 SIRONA DENTAL SYSTEMS GMBH CEREC3 VITABLOCKS 11/01/2001
K851388 SPECIALITES SEPTODONT SEPTOSIL SILICONE FOR PRECISION IMPRESSION 05/29/1985
K161774 SPIDENT Co., Ltd. i-Sil 09/30/2016
K110378 SPOFADENTAL IMPRESSION COMPOUND 04/05/2011
K043054 SULTAN CHEMISTS, INC. GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL 02/18/2005
K030414 SULTAN CHEMISTS, INC. GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL 04/09/2003
K052409 SULTAN CHEMISTS, INC. SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIAL 10/20/2005
K854855 SYBRON CORP. PROOF ALGINATE IMPRESSION MATERIAL 01/30/1986
K820183 SYBRON CORP. SYBRON/KERR MIRROR 3 02/24/1982
K160097 Sybron Dental Specialties Image Fast Set, Image Regular Set 08/05/2016
K130869 SYBRON DENTAL SPECIALTIES TAKE 1 ADVANCE 05/30/2013
K982917 SYBRON DENTAL SPECIALTIES, INC. B-SYSTEM SILICONE 10/16/1998
K051933 SYBRON DENTAL SPECIALTIES, INC. EXPASYL POWER APPLICATOR 01/03/2006
K940379 SYBRON DENTAL SPECIALTIES, INC. EXTRUDE 03/22/1994
K012405 SYBRON DENTAL SPECIALTIES, INC. EXTRUDE MODIFIED 09/04/2001
K050604 SYBRON DENTAL SPECIALTIES, INC. KERR VPS IMPRESSION MATERIAL 04/15/2005
K003650 SYBRON DENTAL SPECIALTIES, INC. PERMLASTIC 3 02/15/2001
K003808 SYBRON DENTAL SPECIALTIES, INC. TAKE 1 03/01/2001
K001876 SYBRON DENTAL SPECIALTIES, INC. TAKE 1 BITE 07/21/2000
K954662 TAK SYSTEMS THERMALASTIC/TRIPOLYVINALENE 11/15/1995
K952422 TELEDYNE WATER PIK ELASTIC IMPRESSION CREAM 08/29/1995
K970594 TELEDYNE WATER PIK KALGINATE IMPRESSION MATERIAL 03/31/1997
K771938 THE S. S. WHITE CO. ALGINATE IMPRESSION MATERIAL 11/02/1977
K780164 TYDONT, INC. RTV DENTAL SILICONE 03/15/1978
K802189 U.S. SHIZAI CORP. DENTLOID 09/26/1980
K940860 ULTRADENT PRODUCTS, INC. CHROMACLONE COLOR CHANGING ALGINATE IMPRESS MATERIALS 05/27/1994
K955892 VAN R DENTAL PRODUCTS, INC. HYDROCOLLOID TRAY MATERIALS, MED. TO HIGH VISCOSITY/WASH MATERIALS, LOW VISCOSITY 03/05/1996
K152518 VERICOM CO., LTD Vonflex S Putty 11/30/2015
K103164 VERICOM CO., LTD. VONFLEX HEAVY, VINFLEX LIGHT 11/10/2010
K091267 VERICOM CO., LTD. VONFLEX PUTTY 05/06/2009
K152615 VERICOM CO., LTD. Vonflex S 11/03/2016
K140966 VERICOM CO., LTD. VONFLEX S BITE 08/15/2014
K955406 VIDENT SCAN WHITE 12 ML 12/28/1995
K895901 VIDENT VITA CEREC SET AND VITA CEREC BLOCS 01/17/1992
K110050 VOCO GMBH FIT TEST C&B 03/28/2011
K051535 VOCO GMBH MODIFICATION TO:REGISTRADO X-TRA 06/28/2005
K022066 VOCO GMBH REGISTRADO X-TRA 08/14/2002
K890449 WACKER-CHEMIE GMBH PERMAGUM PUTTY SOFT & PERMAGUM GARRANT 07/27/1989
K940120 WALLACE A. ERICKSON & CO. ALPHA-DENT 02/25/1994
K790595 WALLACE A. ERICKSON & CO. DENTAL ALGINATE IMPRESSION MATERIAL 06/15/1979
K790592 WALLACE A. ERICKSON & CO. IMPRESSION MATERIAL, RUBBER 06/15/1979
K830044 WALLACE A. ERICKSON & CO. ODONTIC CENTRIC(BITE) REGIST. PASTE 04/06/1983
K912001 WILDE DENTAL (USA) CONVERTRAY, MODIFICATION 01/09/1992
K913583 WILDE-USA, INC. CONVERSIL FL AND CONVERSIL P 11/13/1991
K921571 WYKLE RESEARCH, INC. 1ST IMPRESSION 09/10/1993
K935888 ZHERMACK DENTAL PRODUCTION ELITE FAST LIGHT BODY 08/23/1994
K935885 ZHERMACK DENTAL PRODUCTION ELITE FAST PUTTY SOFT 08/23/1994
K935886 ZHERMACK DENTAL PRODUCTION ELITE LIGHT BODY 08/23/1994
K931242 ZHERMACK DENTAL PRODUCTION ELITE PUTTY HARD 08/23/1994
K935884 ZHERMACK DENTAL PRODUCTION ELITE PUTTY SOFT 08/23/1994
K935887 ZHERMACK DENTAL PRODUCTION ELITE REGULAR BODY 08/23/1994
K935898 ZHERMACK DENTAL PRODUCTION HYDROGUM 08/22/1995
K935892 ZHERMACK DENTAL PRODUCTION INDURENT GEL 10/17/1995
K935889 ZHERMACK DENTAL PRODUCTION OCCLUFAST 08/23/1994
K935896 ZHERMACK DENTAL PRODUCTION THIXOFLEX 09/09/1994
K935890 ZHERMACK DENTAL PRODUCTION ZETAPLUS (PUTTY) 09/08/1995
K053619 ZHERMACK S.P.A. COLORBITE 03/01/2006
K070677 ZHERMACK S.P.A. COLORISE 05/11/2007
K081084 ZHERMACK S.P.A. COLORISE RIGID 05/14/2008
K073005 ZHERMACK S.P.A. ELITE GLASS 12/12/2007
K972027 ZHERMACK S.P.A. ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,) 07/16/1997
K972239 ZHERMACK S.P.A. ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING 08/01/1997
K050417 ZHERMACK S.P.A. ELITE IMPLANT 07/19/2005
K022653 ZHERMACK S.P.A. ELITE MONOPHASE 10/28/2002
K070700 ZHERMACK S.P.A. FREEALGIN 04/25/2007
K974704 ZHERMACK S.P.A. HYDROGUM 01/29/1998
K051424 ZHERMACK S.P.A. HYDROGUM 5 07/15/2005
K043118 ZHERMACK S.P.A. HYDROGUM SOFT 01/24/2005
K083739 ZHERMACK S.P.A. HYDRORISE AND HYDROSYSTEM 03/26/2009
K981091 ZHERMACK S.P.A. NEOCOLLOID, ORTHOPRINT 05/21/1998
K080130 ZHERMACK S.P.A. OCCLUFAST CAD 03/14/2008
K024034 ZHERMACK S.P.A. OCCLUFAST ROCK 12/18/2002
K963609 ZHERMACK S.P.A. PHASE PLUS 11/14/1996
K043131 ZHERMACK S.P.A. TORPICALGIN 12/15/2004
K024041 ZHERMACK S.P.A. ZETAPLUS SOFT 12/18/2002


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact