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 |
| 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 |
| K190217 | Aidite (Qinhuangdao) Technology Co., Ltd. | Aidite PMMA | 12/17/2020 |
| K223477 | Aidite (Qinhuangdao) Technology Co., Ltd. | PMMA Blocks for Dental Use | 02/16/2023 |
| K191843 | Amann Girrbach AG | Ceramill A-Temp | 10/04/2019 |
| K023079 | ANAXDENT GMBH | NEW OUTLINE | 10/30/2002 |
| K210817 | Arum Dentistry Co., Ltd | C&B 5.0 Hybrid | 12/08/2021 |
| K193553 | BEGO Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG | VarseoSmile Temp | 05/18/2020 |
| 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 |
| K182065 | Blue Dent Dental | EVOLUX CAD/CAM PMMA BLOCKS | 12/13/2018 |
| K052781 | BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT | BREFORMANCE | 12/09/2005 |
| K101814 | CANDULOR USA, INC. | DIRECT CROWN NATURAL 1 | 09/27/2010 |
| K123638 | CENDRES & METAUX SA | PEKKTON IVORY | 02/21/2013 |
| 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 |
| K200039 | DeltaMed GmbH | P pro Crown & Bridge | 07/31/2020 |
| 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 |
| K192806 | Dentca, Inc. | DENTCA Crown and Bridge | 02/05/2020 |
| K180657 | Dentis Co., Ltd. | Resin for Temporary Crown & Bridge | 12/07/2018 |
| 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 |
| K994012 | DETAX GMBH & CO. KG | TEMPOFIT, MODEL 02693 | 02/16/2000 |
| K200273 | DETAX GmbH & Co.KG | FREEPRINT temp | 10/27/2020 |
| K192158 | Diadent Group International | DiaTemp | 02/13/2020 |
| K192022 | Diadent Group International | DiaTemp Flow | 02/13/2020 |
| K183337 | DMG Chemisch-Pharmazeutische Fabrik GmbH | LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 | 05/29/2019 |
| 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 |
| K192830 | DMP Dental Industry S.A. | Bright Temporary C&B | 09/02/2020 |
| K171729 | Dreve Dentamid GmbH | Fixtemp C&B | 12/13/2017 |
| K191590 | Enlighten Materials Co., Ltd | AA temp temporary restoration 3D printing photoreactive resin | 05/05/2020 |
| K211101 | EnvisionTEC GmbH | E-Temp | 06/14/2021 |
| K002364 | ESPE DENTAL AG | PROTEMP H | 08/10/2000 |
| K102917 | EXACTA DENTAL DIRECT, INC | FIXTEMP C&B | 06/17/2011 |
| K001884 | FLEXIBLE DIMENSIONS LLC. | DIRECT CROWN | 10/25/2000 |
| K193113 | GC America Inc. | GC Temp Print | 07/09/2020 |
| 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 |
| K213643 | Guangzhou Heygears Imc. Inc | UltraPrint-Dental Temp C&B UV | 01/14/2022 |
| K961198 | HARRY J. BOSWORTH CO. | BOSWORTH CH I | 05/24/1996 |
| K961199 | HARRY J. BOSWORTH CO. | BOSWORTH TEMPORARY RESIN | 06/25/1996 |
| K180578 | Harvest Dental Products, LLC | Harvest Dental Polymer Blocks | 12/12/2018 |
| 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 |
| K201683 | Huge Dental Material Co., Ltd. | PMMA Block | 11/03/2020 |
| K223706 | Huliang(shanghai) Bio-Tech Co., Ltd. | PMMA BLOCK | 05/12/2023 |
| K033432 | IMTEC CORP. | LEXATITE QUICK ACRYLIC | 01/15/2004 |
| K024282 | INOVATIV, LLC | ACRYLIC | 03/21/2003 |
| K022030 | INOVATIV, LLC | POLY-CARB | 08/28/2002 |
| K003377 | IVOCLAR NORTH AMERICA, INC. | FERMIT N PLUS | 12/04/2000 |
| K003374 | IVOCLAR NORTH AMERICA, INC. | FERMIT PLUS | 12/04/2000 |
| 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 |
| 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 |
| 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 |
| K190724 | Meta Biomed Co., Ltd | MD-Temp Plus | 07/03/2019 |
| K061530 | META BIOMED CO., LTD. | MD-TEMP | 07/21/2006 |
| K202965 | Mgnewton LTD. | CURA-Temp | 12/21/2022 |
| 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 |
| K111666 | NEO DENTAL CHEMICAL PRODUCTS CO., LTD. | EVADYNE TEMPORARY CROWN AND BRIDGE RESIN | 09/07/2011 |
| K192153 | New Stetic S.A. | Portux CAD/CAM Disc | 11/07/2019 |
| K110484 | NOVOCOL, INC. | SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL | 05/17/2011 |
| K012360 | PARKELL, INC. | LC TEMPORARY FILLING | 09/06/2001 |
| K991270 | PARKELL, INC. | SMARTEMP | 05/21/1999 |
| K190930 | Parkell, Inc. | SmarTemp X1 | 09/05/2019 |
| 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 |
| K201827 | Pro3dure Medical GmbH | GR-17 Resin System | 11/05/2020 |
| 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 |
| K201563 | Quest Dental USA Corp. | PuRE PMMA Disc | 04/09/2021 |
| K141421 | RIZHAO HUGE DENTAL INDUSTRY CO., LTD | PMMA BLOCK | 02/09/2015 |
| 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 |
| K041886 | SCIENTIFIC PHARMACEUTICALS, INC. | PROVISO | 08/04/2004 |
| K960938 | SILICON-UND COMPOSITE SPEZIALITATEN GMBH | PROV-KB | 04/18/1996 |
| K214071 | SPIDENT CO., LTD. | Hexa-Temp | 03/10/2022 |
| 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 |
| K040769 | VOCO GMBH | STRUCTUR 2 SC | 04/07/2004 |
| K120779 | VOCO GMBH | STRUCTUR 3 | 06/01/2012 |
| K201090 | VOCO GmbH | Structur CAD | 09/09/2020 |
| 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 |
| K191619 | Zest Anchors, LLC | TurboTemp EZ | 09/11/2019 |
| K180562 | Zirkonzahn Gmbh | TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT | 06/28/2018 |
| K200676 | Zirkonzahn srl | ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA | 07/08/2020 |
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