FDA 510(k) Applications for Medical Device Product Code "EBG"
(Crown And Bridge, Temporary, Resin)

FDA 510(k) Number Applicant Device Name Decision Date
K001114 3M COMPANY 3M QUIK TEMP TEMPORIZATION MATERIAL 06/09/2000
K970168 3M COMPANY 3M QUIKPLUS SYSTEM 02/27/1997
K944981 3M COMPANY 3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM 12/02/1994
K935041 3M COMPANY 3M TEMPORARY CROWN & BRIDGE MATERIAL 01/26/1994
K151144 3M DEUTSCHLAND GMBH SuPro 100 09/14/2015
K033022 3M ESPE AG DENTAL PRODUCTS PROTEMP 3 GARANT 11/21/2003
K073296 3M ESPE AG DENTAL PRODUCTS TEMPXN28 01/09/2008
K922559 ACUFEX MICROSURGICAL, INC. ACUFEX ENDOFIX BUTTON 12/24/1992
K900389 ADVANTAGE DENTAL PRODUCTS, INC. TEMPORARY CROWN MATRIX BUTTONS 07/13/1990
K023079 ANAXDENT GMBH NEW OUTLINE 10/30/2002
K112186 BIOLOREN SRL FIBER DISK AND BLOCK 11/08/2011
K073263 BISCO, INC. PRO-V 02/14/2008
K103514 BISCO, INC. PRO-V COAT 05/25/2011
K052781 BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT BREFORMANCE 12/09/2005
K771254 BRIAR CLIFF, INC. ACCU. CROWN COLD CURE 07/15/1977
K101814 CANDULOR USA, INC. DIRECT CROWN NATURAL 1 09/27/2010
K123638 CENDRES & METAUX SA PEKKTON IVORY 02/21/2013
K833261 COE LABORATORIES, INC. INTERIM TEMP. CROWN & BRIDGE RESIN 01/03/1984
K041098 COLTENE AG COOL TEMP NATURAL 05/13/2004
K980799 COSMEDENT, INC. HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL 10/28/1998
K060881 COSMEDENT, INC. TEMPORARY CROWN & BRIDGE RESIN 05/16/2006
K102753 DANVILLE MATERIALS, INC. TURBO TEMP 3 02/04/2011
K102776 DELTAMED GMBH EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM 02/18/2011
K781244 DEN-MAT CORP. TEMP. CROWN MSTERIAL FOR TEETH 08/31/1978
K153490 DENTAL DIREKT GMBH DD medical polymers 05/13/2016
K000894 DENTAL VENTURES OF AMERICA, INC. C&B RESIN PLUS POWDER/LIQUID, MODELS RETEMP A2, A3, A3.5, CL, RETEMP B2, B3, C2, D3, WH, RETEMP MO 05/19/2000
K152215 DENTALPLUS GMBH DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR 01/19/2016
K904251 DENTIFAX INTERN, INC. NEW TRIAD VLC CROWN & BRIDGE PROVISIONAL MATERIAL 06/06/1991
K061264 DENTSPLY INTERNATIONAL, INC. TEMPFX ESTHETIC PROVISIONAL SYSTEM 05/23/2006
K060293 DENTSPLY INTERNATIONAL, INC. TEMPORARY CROWN AND BRIDGE MATERIAL 02/17/2006
K080311 DENTSPLY INTERNTIONAL MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM 04/18/2008
K853052 DENTSPLY INTL. INTEGRITY 08/16/1985
K994012 DETAX GMBH & CO. KG TEMPOFIT, MODEL 02693 02/16/2000
K924830 DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH LUXATEMP AUTOMIX 04/29/1994
K000951 DMG USA, INC. LUXAFORM 04/05/2000
K033227 DMG USA, INC. LUXAFORM PLUS 01/16/2004
K101710 DMG USA, INC. LUXATEMP ULTRA /STAR 09/28/2010
K013674 DMG USA, INC. LUXATEMP/LUXATEMP SOLAR/INSTATEMP 01/24/2002
K052800 DMG USA, INC. PROVISIONAL INLAY/ONLAY KIT 03/07/2006
K171729 Dreve Dentamid GmbH Fixtemp C&B 12/13/2017
K002364 ESPE DENTAL AG PROTEMP H 08/10/2000
K950203 ESPE GMBH & CO. KG. PROTEMP(R) GARANT 02/02/1995
K875133 ESPE GMBH (US) CAVIT-W 03/01/1988
K822452 ESPE GMBH (US) PROTEMP 09/28/1982
K900436 ESPE GMBH (US) PROTEMP II 03/28/1990
K102917 EXACTA DENTAL DIRECT, INC FIXTEMP C&B 06/17/2011
K001884 FLEXIBLE DIMENSIONS LLC. DIRECT CROWN 10/25/2000
K890829 G-C INTL. CORP. UNIFAST LC 04/17/1989
K942670 GC AMERICA, INC. GC PATTERN RESIN 10/18/1994
K935960 GC AMERICA, INC. GC TEMPRON 03/04/1994
K141562 GC AMERICA, INC. MSN-006 09/05/2014
K003817 GC AMERICA, INC. PATTERN RESIN 01/16/2001
K073106 GC AMERICA, INC. UNIFAST III 04/11/2008
K961198 HARRY J. BOSWORTH CO. BOSWORTH CH I 05/24/1996
K961199 HARRY J. BOSWORTH CO. BOSWORTH TEMPORARY RESIN 06/25/1996
K132937 HARVEST DENTAL PRODUCTS, LLC HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) 05/21/2014
K954976 HEALEX PRODUCTS, INC. POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION) 04/25/1996
K972198 HEALTH-DENT INTL., INC. DENT-TEMP ACRYLIC 12/17/1997
K934283 HERAEUS KULZER, INC. DENTALON PLUS MODIFICATION 12/10/1993
K932034 HERAEUS KULZER, INC. PALAVIT 55 AND DENTACOLOR CONNECTOR 08/06/1993
K771602 HOWMEDICA CORP. MYERSONS SPEC. CROWN & BRIDGE RESIN 08/30/1977
K033432 IMTEC CORP. LEXATITE QUICK ACRYLIC 01/15/2004
K024282 INOVATIV, LLC ACRYLIC 03/21/2003
K022030 INOVATIV, LLC POLY-CARB 08/28/2002
K771257 INTERSTATE DENTAL CO., INC. ACRY TEMP 07/15/1977
K934978 IVOCLAR NORTH AMERICA, INC. FERMIT N LIGHT-CURING TEMPORARY FILLING MATERIAL 12/10/1993
K003377 IVOCLAR NORTH AMERICA, INC. FERMIT N PLUS 12/04/2000
K003374 IVOCLAR NORTH AMERICA, INC. FERMIT PLUS 12/04/2000
K941849 IVOCLAR USA, INC. PROVIPONT C&B 08/17/1994
K040951 IVOCLAR VIVADENT, INC. SR ADORO 05/19/2004
K013869 IVOCLAR VIVADENT, INC. SR IVOCRON 08/28/2002
K042820 IVOCLAR VIVADENT, INC. SYSTEMP.C&B PLUS 12/14/2004
K093708 IVOCLAR VIVADENT, INC. TELIO CAD 03/10/2010
K103379 IVOCLAR VIVADENT, INC. TELIO CS INLAY & TELIO CS ONLAY 02/14/2011
K153753 IVOCLAR VIVADENT, INC. TelioCAD Multi 04/12/2016
K020157 J. MORITA USA, INC. TEMPORARY CROWN AND BRIDGE MATERIAL 03/04/2002
K771530 J. PALMERO SALES CO., INC. TEMP. CROWN ACRYLIC RESIN 08/25/1977
K991564 J.F. JELENKO & CO., INC. JELTEMP 06/23/1999
K063624 KAVO AMERICA KAVO EVEREST C-TEMP 02/08/2007
K001309 KAY SEE DENTAL MFG. CO. HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250 06/13/2000
K110747 KERR CORPORATION TEMPFLEX 06/14/2011
K020178 KERR DENTAL MATERIALS CENTER BELLEGLASS HP MODELING GEL 03/15/2002
K000346 KERR DENTAL MATERIALS CENTER EZ CONNECT 04/14/2000
K020092 KERR DENTAL MATERIALS CENTER TEMPHASE 02/22/2002
K122039 KETTENBACH GMBH & CO KG KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B 12/27/2012
K122025 KTK MEDICAL SUPPLIES GMBH BRIGHTGLASS BRIGHTGLASS M 10/09/2012
K831077 KULZER, INC. DENTALON 09/12/1983
K903317 KULZER, INC. DENTALON PLUS 08/13/1990
K772211 LACTONG CORP. TEMP. ACRYLIC 12/22/1977
K081705 LANG DENTAL MFG. CO., INC. LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN 09/17/2008
K083195 LANG DENTAL MFG. CO., INC. MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN 06/05/2009
K082700 MAJOR PRODOTTI DENTARI S.P.A. TEMPORARY COLD.V AND SELF-CURE DENTINE 12/09/2008
K080556 MERZ DENTAL GMBH ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES 05/02/2008
K061809 MERZ DENTAL GMBH ARTEGRAL IMCROWN 09/13/2006
K071548 MERZ DENTAL GMBH WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED 08/21/2007
K061530 META BIOMED CO., LTD. MD-TEMP 07/21/2006
K103474 MICERIUM S.P.A. ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) 02/07/2011
K093380 MYCONE DENTAL SUPPLY CO., INC. MIZZY EXPRESS 03/05/2010
K800828 MYERSON TOOTH CORP. MYERSON'S SPECIAL CROWN & BRIDGE RESIN 04/29/1980
K111666 NEO DENTAL CHEMICAL PRODUCTS CO., LTD. EVADYNE TEMPORARY CROWN AND BRIDGE RESIN 09/07/2011
K110484 NOVOCOL, INC. SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL 05/17/2011
K802489 OKI SHIKS USA LTD. REIGNING CROWN BRIDGE 11/12/1980
K012360 PARKELL, INC. LC TEMPORARY FILLING 09/06/2001
K991270 PARKELL, INC. SMARTEMP 05/21/1999
K771527 PARKER LABORATORIES, INC. ACCU. CROWN COLD CURE 08/16/1977
K021457 PENTRON CORP. FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL 08/01/2002
K112967 POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY PMMA CAD/CAM DISC 08/28/2012
K900068 PROMETEX, INC. ARISTEE (RESIN, CROWN AND BRIDGES) 04/03/1990
K892710 PROMETEX, INC. ARISTEE (TEMPORARY CROWN & BRIDGE RESIN) 10/24/1989
K853092 PSP DENTAL CO., LTD. PSP C & B TEMP 04/03/1986
K081810 PULPDENT CORPORATION PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL 09/17/2008
K120784 PULPDENT CORPORATION TUFF-TEMP 2.0 06/08/2012
K172281 Quest Dental USA Corp. PuRE PMMA Disc 10/19/2017
K875145 RELIANCE ORTHODONTIC PRODUCTS, INC. MAR BOND 02/26/1988
K141421 RIZHAO HUGE DENTAL INDUSTRY CO., LTD PMMA BLOCK 02/09/2015
K820456 ROHM AND HAAS CO. CROWN & BRIDGE RESIN FOR FABRICAT/DE 03/19/1982
K822722 ROHM AND HAAS CO. CROWN S BRIDGE RESIN 09/30/1982
K010012 S & C POLYMER GMBH LC PROVIFILL 02/14/2001
K133268 SCHUTZ-DENTAL GMBH TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS 02/12/2015
K964691 SCICAN TCB TEMPORARY CROWN AND BRIDGE MATERIAL 02/04/1997
K901077 SCIENTIFIC PHARMACEUTICALS, INC. PRELUDE (TEMPORARY CROWN AND BRIDGE CEMENT) 05/29/1990
K041886 SCIENTIFIC PHARMACEUTICALS, INC. PROVISO 08/04/2004
K960938 SILICON-UND COMPOSITE SPEZIALITATEN GMBH PROV-KB 04/18/1996
K831294 SOLAR DENTAL CO., INC. SOLARCRY/TEMPORARY CROWN & BRIDGE MAT 08/31/1983
K915466 SPECIALITES SEPTODONT SEPTOPACK TEMPORARY FILLING 02/03/1992
K955331 SYBRON DENTAL SPECIALTIES, INC. BELLEGLASHP 01/02/1996
K031476 SYBRON DENTAL SPECIALTIES, INC. FILL-IN 07/02/2003
K013895 SYBRON DENTAL SPECIALTIES, INC. TEMPFIL 02/04/2002
K964981 SYBRON DENTAL SPECIALTIES, INC. TEMPFIL C&B 02/10/1997
K963786 SYBRON DENTAL SPECIALTIES, INC. TEMPFIL F 11/19/1996
K982459 SYBRON DENTAL SPECIALTIES, INC. TEMPFIL F - 2 09/30/1998
K142371 TALLADIUM, INC. Luminesse PMMA 04/24/2015
K140894 THE ARGEN CORPORATION ARGEN PMMA 07/31/2014
K150432 UNION DENTAL S.A. IDODENTINE DISC, IDODENTINE BLOCK 08/14/2015
K102341 VIPI INDUSTRIA,COMERCIO,EXPORTACAO E IMPORTACAO DE VIPI BLOCK 12/16/2010
K070991 VITA VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310 06/01/2007
K802679 VIVADENT (USA), INC. SILANIT 12/17/1980
K941124 VOCO GMBH STRUCTUR 2 04/13/1994
K040769 VOCO GMBH STRUCTUR 2 SC 04/07/2004
K120779 VOCO GMBH STRUCTUR 3 06/01/2012
K091894 VOCO GMBH TEMPORARY C&B COMPOSITE 07/23/2009
K960122 WALLACE A. ERICKSON & CO. ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL 02/21/1996
K152443 WHIP MIX CORPORATION Vericore Gradient Temporary Disc 05/11/2016
K131664 WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG COPRA TEMP PMMA-DISK 12/18/2013
K080182 WIELAND DENTAL + TECHNIK GMBH & CO. KG ZENO PMMA DISC 04/08/2008
K151764 YAMAHACHI DENTAL PRODUCTS USA, INC. YAMAHACHI PMMA DISKS 11/23/2015
K180562 Zirkonzahn Gmbh TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT 06/28/2018


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