FDA 510(k) Applications for Medical Device Product Code "EBF"
(Material, Tooth Shade, Resin)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K981647 | 3M COMPANY | 3M DENT II SYSTEM | 08/09/1998 |
| K072733 | 3M COMPANY | 3M ESPE ADULT CROWN | 02/15/2008 |
| K010781 | 3M COMPANY | 3M ESPE HAUR | 04/13/2001 |
| K991961 | 3M COMPANY | 3M LVR SYSTEM | 08/09/1999 |
| K970500 | 3M COMPANY | 3M SUSTEL DENTAL SYSTEM | 04/30/1997 |
| K163207 | 3M Company | Filtek One Bulk Fill Restorative | 11/28/2016 |
| K100235 | 3M COMPANY | FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE | 05/12/2010 |
| K083610 | 3M COMPANY | FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE | 12/17/2008 |
| K122569 | 3M COMPANY | LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR | 09/12/2012 |
| K221695 | 3M Company ESPE Dental Products | 3M Filtek Supreme Flowable Restorative | 06/13/2022 |
| K033996 | 3M ESPE AG DENTAL PRODUCTS | HERMES | 02/24/2004 |
| K183476 | 3M ESPE Dental Products | 3M Filtek Universal Restorative | 01/02/2019 |
| K120453 | 3M ESPE DENTAL PRODUCTS | FILTEK BULK FILL FLOWABLE RESTORATIVE | 03/19/2012 |
| K141081 | 3M ESPE DENTAL PRODUCTS | FILTEK BULK FILL POSTERIOR RESTROATIVE | 05/08/2014 |
| K110131 | 3M ESPE DENTAL PRODUCTS | LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE | 01/21/2011 |
| K022975 | AB ARDENT | ETCHING 15 | 11/22/2002 |
| K040465 | AB ARDENT | LATIT FLOW | 07/20/2004 |
| K131753 | AB ARDENT | MERIDIAN | 11/14/2013 |
| K022972 | AB ARDENT | MICROFILL 13 | 11/22/2002 |
| K022971 | AB ARDENT | MICROHYBRID 11 | 11/25/2002 |
| K022974 | AB ARDENT | MICROHYBRID 12 | 11/22/2002 |
| K014144 | AFP IMAGING CORP. | EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 | 02/07/2002 |
| K250497 | Aidite (Qinhuangdao) Technology Co., Ltd | Additive Manufacturing (Light Curing) Crown Bridge Resin | 04/30/2025 |
| K223742 | Aidite (Qinhuangdao) Technology Co., Ltd | Dental Ceramic Blocks | 03/08/2023 |
| K112044 | ANAXDENT GMBH | ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A | 01/26/2012 |
| K123823 | ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS | INTERLIG | 05/31/2013 |
| K062157 | APEX DENTAL MATERIALS, INC. | CONFORM | 10/13/2006 |
| K091647 | APEX DENTAL MATERIALS, INC. | INJECTAFIL | 09/21/2009 |
| K110859 | APEX DENTAL MATERIALS, INC. | METAL OPAQUER | 06/23/2011 |
| K092539 | APEX DENTAL MATERIALS, INC. | SEAMFREE | 10/01/2009 |
| K010849 | APEX DENTAL MATERIALS, INC. | VERTEX ETCHANT | 09/14/2001 |
| K073047 | APROXI APS | APROXI 1100 AND 4000 SERIES DENTAL INLAYS | 08/07/2008 |
| K232559 | Arum Dentistry Co., Ltd. | C&B NFH Hybrid | 09/11/2024 |
| K001799 | AUSTENAL, INC. | DC-TELL | 08/10/2000 |
| K201668 | BEGO Bremer GoldschlΣgerei Wilh. Herbst GmbH & Co. KG | VarseoSmile Crown plus | 06/23/2020 |
| K233596 | BEGO Bremer GoldschlΣgerei Wilh. Herbst GmbH & Co. KG | VarseoSmile TriniQ | 11/09/2023 |
| K143524 | Bicon, LLC | Fiber Disks and Blocks (TRINIA) | 06/02/2015 |
| K133608 | BICON, LLC | TRINIA | 03/14/2014 |
| K190139 | Bioden Co., Ltd | Zircos-Com | 04/24/2020 |
| K173643 | Bioloren S.R.L. | Trilor Disks, Blocks and Arches | 02/24/2018 |
| K121735 | BIOLOREN SRL | FIBER DISK AND BLOCK PERMANENT, TRINIA | 02/21/2013 |
| K012180 | BISCO, INC. | A-WEAR | 09/05/2001 |
| K984112 | BISCO, INC. | ADVENT | 12/22/1998 |
| K093470 | BISCO, INC. | CORE-FLO D/C | 02/17/2010 |
| K993192 | BISCO, INC. | ILLUSION | 10/27/1999 |
| K993488 | BISCO, INC. | LIGHT-CORE | 11/10/1999 |
| K974483 | BISCO, INC. | NTL-FLOW | 02/09/1998 |
| K992248 | BISCO, INC. | POST CEMENT HI-X | 08/25/1999 |
| K982645 | BISCO, INC. | PYRAMID | 09/02/1998 |
| K242816 | Bisco, Inc. | Quantium | 12/17/2024 |
| K982729 | BISCO, INC. | RENEW | 09/15/1998 |
| K003317 | BISCO, INC. | RENEW LS-1 | 11/21/2000 |
| K003361 | BISCO, INC. | RENEW LS-2 | 11/28/2000 |
| K171147 | Bisco, Inc. | REVEAL Bulk | 08/04/2017 |
| K042804 | BISCO, INC. | TESCERA OPAQUER POWDER/SCULPTING RESIN | 02/01/2005 |
| K030951 | BISCO, INC. | TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P | 06/06/2003 |
| K010196 | BISCO, INC. | TOTAL CURE | 04/05/2001 |
| K964931 | BISCO, INC. | WHITE CORE | 02/10/1997 |
| K152113 | Bredent GmbH & Co.KG | BioHPP - breCAM.BioHPP | 07/21/2016 |
| K052779 | BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT | BRECOMP | 12/20/2005 |
| K250763 | C.E.I.B.med | Reon | 05/12/2025 |
| K983549 | CAVEX HOLLAND B.V. | QUADRANT ANTERIOR SHINE | 11/23/1998 |
| K984042 | CAVEX HOLLAND B.V. | QUADRANT CORE LC | 12/04/1998 |
| K984044 | CAVEX HOLLAND B.V. | QUADRANT POSTERIOR DENSE | 12/16/1998 |
| K984043 | CAVEX HOLLAND B.V. | QUADRANT TOTAL ETCH | 12/04/1998 |
| K983751 | CAVEX HOLLAND B.V. | QUADRANT UNICHEM | 11/30/1998 |
| K984041 | CAVEX HOLLAND B.V. | QUADRANT UNIVERSAL LC | 12/04/1998 |
| K170102 | CENDRES+METAUX SA | Pekkton Ivory | 11/13/2017 |
| K963311 | CENTRIX, INC. | TEAM ETCH | 10/07/1996 |
| K973257 | CENTRIX, INC. | VERSAETCH | 11/17/1997 |
| K191385 | Coltene/Whaledent AG | BRILLIANT COMPONEER | 10/29/2019 |
| K181500 | Coltene/Whaledent AG | BRILLIANT Crios | 08/15/2018 |
| K152927 | COLTENE/WHALEDENT AG | BRILLIANT EVERGLOW | 04/28/2016 |
| K190597 | Coltene/Whaledent AG | BRILLIANT EverGlow Flow | 06/21/2019 |
| K112168 | COLTENE/WHALEDENT AG | COMPONEER | 11/21/2011 |
| K150218 | COLTENE/WHALEDENT AG | Fill-Up! | 06/23/2015 |
| K052820 | COLTENE/WHALEDENT AG | PARAPOST PARACORE AUTOMIX 5ML | 01/09/2006 |
| K003034 | COLTENE/WHALEDENT INC. | COLTENE AURA COMPOMER RESTORATIVE SYSTEM | 11/30/2000 |
| K974465 | COLTENE/WHALEDENT INC. | SYNERGY | 03/09/1998 |
| K013400 | COLTENE/WHALEDENT INC. | SYNERGY FLOW | 12/10/2001 |
| K954988 | CONFI-DENTAL PRODUCTS CO. | CRYSTALLESSENCE | 03/08/1996 |
| K211259 | Cosmedent, Inc | Renamel Bulkfill | 06/24/2021 |
| K172707 | Cosmedent, Inc | Renamel Microfill | 12/05/2017 |
| K163480 | Cosmedent, Inc | Renamel NANO +plus | 02/24/2017 |
| K222435 | Cosmedent, Inc | Renamel« Microhybrid ;Renamel« Flowable Microhybrid | 10/11/2022 |
| K092730 | COSMEDENT, INC. | COSMEDENT BRUSHABLE COMPOSITE | 11/20/2009 |
| K040994 | COSMEDENT, INC. | COSMEDENT CORE PASTE | 06/03/2004 |
| K980800 | COSMEDENT, INC. | LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL | 11/09/1998 |
| K070583 | COSMEDENT, INC. | NANO COMPOSITE | 04/16/2007 |
| K993659 | COSMEDENT, INC. | RENAMEL PACK | 01/18/2000 |
| K993658 | COSMEDENT, INC. | RENAMEL SCULPT | 01/18/2000 |
| K222723 | Creamed GmbH & Co. Produktions- und Handels KG | AMBARINO High-Class | 09/09/2022 |
| K110642 | DANVILLE MATERIALS INC. | SILJETR SYSTEM | 05/27/2011 |
| K151514 | DANVILLE MATERIALS LLC | Prestige | 09/21/2015 |
| K121880 | DANVILLE MATERIALS, INC. | DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID | 09/25/2012 |
| K092912 | DANVILLE MATERIALS, INC. | STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150 | 12/16/2009 |
| K020760 | DANVILLE MATERIALS, INC. | STARFLOW HV | 05/03/2002 |
| K151088 | DANVILLE MATERIALS, LLC | DMRC Bulk Fill | 08/28/2015 |
| K993514 | DEGUSSA - NEY DENTAL, INC. | DEFINITE | 02/24/2000 |
| K211804 | DeltaMed GmbH | 3Delta Crown | 12/06/2021 |
| K243720 | DeltaMed GmbH | 3Delta UNlimited | 12/18/2024 |
| K242097 | Den-Mat Holdings, LLC | DenMat Bulk Fill Composite | 10/15/2024 |
| K143679 | Den-Mat Holdings, LLC | Nuance FLOW | 05/01/2015 |
| K162967 | Den-Mat Holdings, LLC | nuance UNIVERSAL | 03/24/2017 |
| K070693 | DENALI CORPORATION | AURAVUE PIT & FISSURE SEALANT | 05/09/2007 |
| K153191 | DENALI CORPORATION | Calcium Bridge | 02/26/2016 |
| K070702 | DENALI CORPORATION | FUSION RESIN CEMENT AND CORE KIT | 05/10/2007 |
| K960565 | DENT ZAR, INC. | ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE | 03/22/1996 |
| K960598 | DENT ZAR, INC. | CONCORD MARYLAND BRIDGE CEMENT | 04/26/1996 |
| K960729 | DENT ZAR, INC. | ENAMEL CONDITIONER (ENAMEL ETCHING AGENT) | 04/26/1996 |
| K960595 | DENT ZAR, INC. | FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS | 04/26/1996 |
| K960600 | DENT ZAR, INC. | LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERS | 04/26/1996 |
| K960594 | DENT ZAR, INC. | LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETS | 04/26/1996 |
| K960597 | DENT ZAR, INC. | ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CURE | 04/26/1996 |
| K960596 | DENT ZAR, INC. | ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE | 04/26/1996 |
| K960599 | DENT ZAR, INC. | SUPERIOR PHOTOCURING HYBRID COMPOSITE | 04/26/1996 |
| K070191 | DENTAL TECHNOLOGIES, INC. | ALPHA-CORE DC | 03/07/2007 |
| K981948 | DENTAL/MEDICAL DIAGNOSTIC SYSTEMS, INC. | APOLLO 95E | 08/18/1998 |
| K030133 | DENTALEZ GROUP | SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE | 04/29/2003 |
| K193496 | Dentkist, Inc. | CharmFil | 05/06/2020 |
| K191389 | Dentscare Ltda | Allcem Veneer APS | 02/25/2020 |
| K191306 | Dentscare LTDA | Llis, Vittra APS | 12/16/2019 |
| K201707 | Dentscare LTDA | Opallis, Opallis Flow | 12/22/2020 |
| K190758 | DentsCare LTDA | Opus Bulk Fill APS, Opus Bulk Fill Flow APS | 09/04/2019 |
| K210231 | Dentscare Ltda | Vittra APS Unique | 10/14/2021 |
| K232994 | Dentscare LTDA | Vittra APS Unique Flow | 10/18/2024 |
| K052097 | DENTSPLY INTERNATIONAL | CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE | 08/12/2005 |
| K040144 | DENTSPLY INTERNATIONAL | QUIXX POSTERIOR RESTORATIVE | 04/01/2004 |
| K083841 | DENTSPLY INTERNATIONAL, INC. | ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL | 04/14/2009 |
| K083326 | DENTSPLY INTERNATIONAL, INC. | FLUOROCORE 2 | 02/10/2009 |
| K973221 | DENTSPLY INTL. | COMPOSITE 168 RESTORATIVE SYSTEM | 02/09/1998 |
| K973235 | DENTSPLY INTL. | DYRACT AP RESTORATIVE | 02/05/1998 |
| K050880 | DENTSPLY INTL. | DYRACT EXTRA RESTORATIVE | 04/22/2005 |
| K982395 | DENTSPLY INTL. | DYTRACT FLOW RESTORATIVE | 08/18/1998 |
| K984387 | DENTSPLY INTL. | R-30 AESTHETIC RESTORATIVE | 01/13/1999 |
| K982318 | DENTSPLY INTL. | SPECTRUM 800 CURING UNIT | 09/15/1998 |
| K182288 | Dentsply Sirona | TPH Spectra ST Flowable Composite Restorative | 11/20/2018 |
| K162107 | DENTSPLY SIRONA | TPH Spectra+ Universal Composite Restorative | 09/27/2016 |
| K222877 | DETAX GmbH | FREEPRINT crown | 09/23/2022 |
| K210421 | Diadent Group International | Diafil & Diafil Capsule | 06/28/2021 |
| K192510 | Diadent Group International | DIAFIL & DIAFIL Capsule | 03/20/2020 |
| K192284 | Diadent Group International | DiaFil Flow | 03/25/2020 |
| K101215 | DISCUS DENTAL, LLC | NUANCE | 05/12/2010 |
| K171772 | DMG USA Inc. | Ecosite Bulk Fill | 01/31/2018 |
| K011211 | DMG USA, INC. | FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW | 06/18/2001 |
| K012307 | DMG USA, INC. | LUXACORE/LUXACORE DUAL | 08/23/2001 |
| K013571 | DMG USA, INC. | MAGICFIL | 01/17/2002 |
| K080480 | DMG USA, INC. | NANOCOMPOSITE RESTORATIVE KIT | 05/30/2008 |
| K002086 | DMG USA, INC. | PRIMAFLOW | 08/17/2000 |
| K102603 | DMG USA, INC. | SA FLOWABLE ADHESIVE | 11/17/2010 |
| K121915 | DMP LTD | BRIGHT RESTORATIVE MATERIALS | 09/28/2012 |
| K102255 | DMP LTD | DMP ETCHING GEL | 11/23/2010 |
| K102257 | DMP LTD | NANOCERAM- BRIGHT | 11/19/2010 |
| K011839 | DOXA CERTEX AB | DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C | 01/17/2002 |
| K250778 | DSI Dental Solutions Ltd | Sil-Flow | 05/23/2025 |
| K231142 | DWS s.r.l. | Temporis, Irix Plus | 04/25/2024 |
| K241131 | Edelweiss Dentistry Products GmbH | edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK | 10/18/2024 |
| K962405 | EFOS CANADA, INC. | SANICURE DISPOSABLE CURING PROBE | 08/29/1996 |
| K210977 | EnvisionTEC GmbH | E-Dent 1000 | 05/25/2021 |
| K990982 | ESPE DENTAL AG | CAVIT LC | 04/23/1999 |
| K992909 | ESPE DENTAL AG | HYTAC | 11/24/1999 |
| K994251 | ESPE DENTAL AG | KETAC-MOLAR QUICK | 01/03/2000 |
| K993566 | ESPE DENTAL AG | PROMPTFLOW | 12/06/1999 |
| K992966 | ESPE DENTAL AG | REFERENCE | 10/07/1999 |
| K992645 | ESPE DENTAL AG | SINFONY | 09/22/1999 |
| K972892 | ESPE GMBH & CO. KG. | CAVIT-LC | 10/02/1997 |
| K963735 | ESPE GMBH & CO. KG. | COJET SYSTEM | 11/27/1996 |
| K962442 | ESPE GMBH & CO. KG. | HYTAC APLITIP/HYTAC OSB | 09/11/1996 |
| K962440 | ESPE GMBH & CO. KG. | PERTAC II/PERTAC II APLITIP | 09/11/1996 |
| K973513 | ESPE GMBH & CO. KG. | SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER | 12/22/1997 |
| K172952 | Figaro Crowns, Inc. | Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit | 07/03/2018 |
| K011309 | FIRST SCIENTIFIC LIMITED | LUTE VLC; CORE VLC | 06/22/2001 |
| K011517 | FIRST SCIENTIFIC LIMITED | LUTE; CORE | 07/10/2001 |
| K011295 | FIRST SCIENTIFIC LIMITED | RESTORE-PF VIC; RESTORE-PF VLC CAPSULE | 06/27/2001 |
| K981813 | FOREMOST DENTAL MFG., INC. | PERMACEM AUTOMIX LUTING CEMENT SYSTEM | 07/10/1998 |
| K982201 | FOREMOST DENTAL MFG., INC. | ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) | 08/10/1998 |
| K970683 | FOREMOST DENTAL MFG., INC. | ZENTIH FLOWABLE COMPOSITE (MULTIPLE) | 07/15/1997 |
| K192260 | GC America Inc. | everX Flow | 11/22/2019 |
| K153127 | GC AMERICA INC. | everX Posterior | 05/20/2016 |
| K151541 | GC America Inc. | G-Fix | 10/09/2015 |
| K070190 | GC AMERICA INC. | GRADIA DIRECT X | 03/12/2007 |
| K153325 | GC America Inc. | Gradia Plus | 07/12/2016 |
| K173500 | GC America Inc. | NMF004A | 03/08/2018 |
| K082171 | GC AMERICA, INC | GRADIA CORE | 10/30/2008 |
| K133824 | GC AMERICA, INC. | CERASMART | 03/14/2014 |
| K993973 | GC AMERICA, INC. | FUJI II LC CAPSULE | 01/11/2000 |
| K091388 | GC AMERICA, INC. | GCUC-505 | 07/22/2009 |
| K082434 | GC AMERICA, INC. | GDLS-200 | 11/14/2008 |
| K001518 | GC AMERICA, INC. | GRADIA | 07/05/2000 |
| K023814 | GC AMERICA, INC. | GRADIA DIRECT | 01/30/2003 |
| K042348 | GC AMERICA, INC. | GRADIA DIRECT LOFLO | 11/18/2004 |
| K080478 | GC AMERICA, INC. | GRADIA FORTE | 06/05/2008 |
| K033808 | GC AMERICA, INC. | GRADIA GUM | 02/02/2004 |
| K133182 | GC AMERICA, INC. | HTFX-222 | 04/09/2014 |
| K123631 | GC AMERICA, INC. | MFP-051 | 07/23/2013 |
| K090747 | GC AMERICA, INC. | MI FLOW (GCUC-450) | 06/10/2009 |
| K020342 | GC AMERICA, INC. | UNIFIL FLOW | 03/28/2002 |
| K200155 | GENOSS Co., Ltd. | Bright High Flow | 11/30/2020 |
| K200156 | Genoss co.,Ltd. | Bright Low Flow | 10/27/2020 |
| K220329 | Graphenano Dental S.L. | G-CAM | 08/16/2022 |
| K202846 | Graphy Inc. | TERA HARZ | 07/15/2021 |
| K233502 | Graphy Inc. | TERA HARZ II | 11/01/2023 |
| K180463 | Greenway YW LLC | Apoller Flow Light Cure Flowable Composite | 11/14/2018 |
| K021250 | HANDPIECE UNLIMITED | MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD) | 10/24/2002 |
| K991491 | HARRY J. BOSWORTH CO. | FLC COMPOSITE | 06/21/1999 |
| K993716 | HARRY J. BOSWORTH CO. | PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE | 12/21/1999 |
| K991488 | HARRY J. BOSWORTH CO. | SELF CURE COMPOSITE | 06/21/1999 |
| K213339 | HDI, Inc. | DENU Composite Resin, DENU Flow Resin | 09/23/2022 |
| K073554 | HERAEUS KULZER GMBH | NEUN | 02/04/2008 |
| K062515 | HERAEUS KULZER GMBH | RETENTION FLOW OPAQUE | 11/22/2006 |
| K990756 | HERAEUS KULZER, INC. | FLOW LINE | 05/07/1999 |
| K993602 | HERAEUS KULZER, INC. | PRE-VISION FILL | 12/15/1999 |
| K993932 | HERAEUS KULZER, INC. | SOLITAIRE 2 | 12/22/1999 |
| K033665 | HERAEUS KULZER, INC. | VENUS FLOW | 12/30/2003 |
| K020131 | HERAEUS KULZER, INC. | VENUS UNIVERSAL LIGHT CURING COMPOSITE | 02/28/2002 |
| K112501 | HERAEUS KULZER, LLC | VENUS PEARL PLT REFILL A1 | 12/14/2011 |
| K160049 | Heraeus Kulzer, LLC (Mitsui Chemicals Group) | Charisma | 11/15/2016 |
| K192178 | Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. | R&D Series Nova Compo N | 12/20/2019 |
| K220077 | IMICRYL DIS MALZEMELERI SANAYI VE TICARET AS | IMICRYL Composite, Composite Flow Materials | 08/09/2022 |
| K010219 | INTERNATIONAL DENTAL RESEARCH | CHALLENGER DIRECT COMPOSITE | 02/21/2001 |
| K121769 | ITENA CLINICAL | DENTOCORE / DENTOCORE BODY | 03/05/2013 |
| K971513 | IVOCLAR NORTH AMERICA, INC. | COMPOGLASS F | 06/03/1997 |
| K974577 | IVOCLAR NORTH AMERICA, INC. | COMPOGLASS FLOW | 01/30/1998 |
| K011492 | IVOCLAR NORTH AMERICA, INC. | IN TEN-S | 07/05/2001 |
| K990315 | IVOCLAR NORTH AMERICA, INC. | MONOPAQUE | 03/04/1999 |
| K962878 | IVOCLAR NORTH AMERICA, INC. | TARGIS SYSTEM | 09/25/1996 |
| K964285 | IVOCLAR NORTH AMERICA, INC. | TETRIC CERAM | 01/22/1997 |
| K010250 | IVOCLAR NORTH AMERICA, INC. | TETRIC CERAM HB | 02/28/2001 |
| K993783 | IVOCLAR NORTH AMERICA, INC. | TETRIC FLOW | 12/13/1999 |
| K971372 | IVOCLAR NORTH AMERICA, INC. | VARIOLINK II | 05/29/1997 |
| K981264 | IVOCLAR USA, INC. | ARISTON PHC | 07/02/1998 |
| K033773 | IVOCLAR VIVADENT AG | CONCEPT HP ADD-ON; CONCEPT HP ENAMEL | 01/15/2004 |
| K121230 | IVOCLAR VIVADENT AG | IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE | 08/29/2012 |
| K123397 | IVOCLAR VIVADENT AG | MULTILINK AUTOMIX | 01/31/2013 |
| K123304 | IVOCLAR VIVADENT AG | SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO | 01/24/2013 |
| K173573 | Ivoclar Vivadent AG | Tetric CAD | 06/07/2018 |
| K150393 | IVOCLAR VIVADENT AG | TETRIC EVOFLOW BULK FILL | 06/09/2015 |
| K142389 | IVOCLAR VIVADENT AG | Variolink Esthetic | 11/25/2014 |
| K183380 | Ivoclar Vivadent, AG | Tetric PowerFill | 03/14/2019 |
| K024094 | IVOCLAR VIVADENT, INC. | 4 SEASONS | 02/14/2003 |
| K090701 | IVOCLAR VIVADENT, INC. | EMPRESS DIRECT | 04/29/2009 |
| K013929 | IVOCLAR VIVADENT, INC. | HELIOMOLAR HB TRANSLUCENT SHADES | 02/07/2002 |
| K103528 | IVOCLAR VIVADENT, INC. | IPS EMPRESS DIRECT FLOW | 02/25/2011 |
| K040795 | IVOCLAR VIVADENT, INC. | MULTICORE HB; MULTICORE FLOW | 05/17/2004 |
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| K971898 | ULTRADENT PRODUCTS, INC. | PERMALUTE, TRY-IN PASTE | 06/24/1997 |
| K965060 | ULTRADENT PRODUCTS, INC. | ULTRA-ETCH STAT | 01/31/1997 |
| K974282 | ULTRADENT PRODUCTS, INC. | VITALESCENCE | 01/29/1998 |
| K020113 | VECTOR RESEARCH & DEVELOPMENT | VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES | 05/17/2002 |
| K042124 | VERICOM CO., LTD. | DENFIL | 08/13/2004 |
| K080265 | VERICOM CO., LTD. | DENFIL ETCHANT-37 | 02/06/2008 |
| K060637 | VERICOM CO., LTD. | DENFIL FLOW | 03/16/2006 |
| K163346 | VERICOM CO., LTD. | MAZIC Duro | 03/17/2017 |
| K072069 | VERICOM CO., LTD. | SPACER | 09/28/2007 |
| K961434 | VIDENT | VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEM | 07/08/1996 |
| K152373 | VITA ZAHNFABRIK H. RAUTER GMBH & CO. | VITA VM LC Flow | 12/30/2015 |
| K994056 | VOCO GMBH | ADMIRA | 01/12/2000 |
| K011756 | VOCO GMBH | ADMIRA FLOW | 07/18/2001 |
| K150784 | VOCO GMBH | Admira Fusion | 07/02/2015 |
| K230877 | VOCO GmbH | Admira Fusion 5 | 07/13/2023 |
| K153177 | VOCO GMBH | Admira Fusion Flow | 06/30/2016 |
| K170896 | VOCO GmbH | Admira Fusion x-base | 06/29/2017 |
| K151956 | VOCO GMBH | Admira Fusion x-tra | 10/20/2015 |
| K090843 | VOCO GMBH | AMARIS GINGIVA OPAQUER | 06/17/2009 |
| K071386 | VOCO GMBH | AMARIS/AMARIS FLOW | 06/05/2007 |
| K994304 | VOCO GMBH | ARABESK FLOW | 02/07/2000 |
| K994268 | VOCO GMBH | ARABESK TOP | 02/03/2000 |
| K062345 | VOCO GMBH | CERAMIC BOND | 12/15/2006 |
| K110589 | VOCO GMBH | CIMARA | 05/27/2011 |
| K153493 | VOCO GmbH | Clip Flow | 07/29/2016 |
| K051867 | VOCO GMBH | GRANDIO | 07/27/2005 |
| K030915 | VOCO GMBH | GRANDIO | 05/30/2003 |
| K171200 | VOCO GmbH | Grandio blocs | 08/10/2017 |
| K112447 | VOCO GMBH | GRANDIO CORE DUAL CURE | 11/08/2011 |
| K033117 | VOCO GMBH | GRANDIO FLOW | 11/25/2003 |
| K051868 | VOCO GMBH | GRANDIO FLOW | 07/27/2005 |
| K101213 | VOCO GMBH | GRANDIO FLOW | 08/19/2010 |
| K062343 | VOCO GMBH | GRANDIO FLOW TRY-IN | 11/02/2006 |
| K102351 | VOCO GMBH | GRANDIO SO | 11/02/2010 |
| K103580 | VOCO GMBH | GRANDIO SO FLOW | 01/21/2011 |
| K102354 | VOCO GMBH | GRANDIO SO HEAVY FLOW | 11/08/2010 |
| K200294 | VOCO GmbH | GrandioSO Light Flow | 03/27/2020 |
| K251239 | VOCO GmbH | GrandioSO Unlimited | 05/21/2025 |
| K181312 | VOCO GmbH | GrandioSO x-tra | 08/22/2018 |
| K102450 | VOCO GMBH | IONOLUX PRO | 10/08/2010 |
| K060893 | VOCO GMBH | MODIFICATION TO REBILDA DC | 05/25/2006 |
| K113563 | VOCO GMBH | N-HYBRIDE-COMPOSITE LC | 12/21/2011 |
| K113444 | VOCO GMBH | N-HYBRIDE-COMPOSITE LC FLOW | 12/21/2011 |
| K030914 | VOCO GMBH | REBILDA DC | 05/30/2003 |
| K014111 | VOCO GMBH | REBILDA SC | 03/06/2002 |
| K171815 | VOCO GmbH | Registrado Scan | 11/15/2017 |
| K022797 | VOCO GMBH | TWINKY STAR | 10/10/2002 |
| K063604 | VOCO GMBH | TWINKY STAR NF | 01/22/2007 |
| K201307 | VOCO GmbH | VisCalor | 07/08/2020 |
| K190453 | VOCO GmbH | VisCalor bulk | 04/11/2019 |
| K112374 | VOCO GMBH | X-TRA BASE | 10/20/2011 |
| K123773 | VOCO GMBH | X-TRA BASE | 12/21/2012 |
| K053391 | VOCO GMBH | X-TRA FIL | 02/15/2006 |
| K960165 | WALLACE A. ERICKSON & CO. | ALPHA-DENT COMPOSITE SURFACE SEALANT | 03/15/1996 |
| K960667 | WALLACE A. ERICKSON & CO. | CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE | 07/02/1996 |
| K962909 | WILLIAM J. DAY | DENTAL PREP WASH AND PREP DISINFECT | 10/07/1996 |
| K181484 | Zirkonzahn Srl | Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue | 06/18/2018 |
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