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 |
| 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 |
| K220257 | 3M Deutschland GmbH | Permadyne | 02/01/2022 |
| 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 |
| K963205 | AMERICAN TOOTH INDUSTRIES | ALGINMAX, ORTHOCHROME | 10/29/1996 |
| K113263 | ARGES IMAGING, INC | ARGES IMAGING CONTRAST SPRAY | 11/14/2011 |
| K072577 | BISICO GMBH & CO KG | BISICO IMPRESSION SILICONES & ALGINATES | 12/05/2007 |
| K131510 | BLACKWELL DEVICE CONSULTING | POLYDIMETHYLSILOXANE IMPRESSION MATERIAL | 12/20/2013 |
| 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 |
| K152826 | CENTRIX, INC. | NoCord | 05/27/2016 |
| K221668 | Chemoment Materials Co.,ltd | Dental Impression Material | 08/08/2022 |
| 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 |
| K051243 | COLTENE/WHALEDENT AG | JET BLUE BITE | 06/23/2005 |
| K050013 | COLTENE/WHALEDENT AG | RETRACTOFOAM | 02/09/2005 |
| K220097 | ColtΦne/Whaledent AG | PRESIDENT The Original | 01/13/2022 |
| K073475 | CONTINENTAL DENTAL LABORATORY | SYSTEM PLUS | 03/10/2008 |
| K041229 | COSMEDENT, INC. | MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) | 06/17/2004 |
| K041028 | CROWN DELTA CORP. | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL | 05/14/2004 |
| 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 |
| K983106 | DEN-MAT CORP. | 1ST IMPRESSION | 02/09/1999 |
| 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 |
| 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 |
| K952614 | DENTSPLY INTL. | JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL | 08/13/1996 |
| K061427 | DENTSPLY INTL. | PRE-IMPRESSION CONDITIONING SOLUTION | 06/26/2006 |
| 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 |
| K190571 | Dreve Dentamid GmbH | StoneBite and StoneBite scan | 11/07/2019 |
| 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 |
| K960547 | ESPE GMBH & CO. KG. | DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE | 03/15/1996 |
| K974231 | ESPE GMBH & CO. KG. | POSITION PENTA, POSITION PENTA QUICK | 01/29/1998 |
| 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 |
| K181011 | GC America Inc. | AIM2 | 07/12/2018 |
| K994077 | GC AMERICA, INC. | AROMA FINE (NORMAL AND FAST SET) | 01/27/2000 |
| 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 |
| 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 |
| K214086 | Genoss Co., Ltd. | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty | 12/15/2022 |
| 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 |
| K222741 | HDI, Inc. | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) | 11/07/2022 |
| 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 |
| 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 |
| K030318 | HERAEUS KULZER, INC. | P2 POLYETHER | 04/03/2003 |
| 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 |
| K203824 | Hygedent INC. | VPS Impression Material | 04/19/2021 |
| K191034 | Hygedent Inc. | VPS Impression Material | 09/04/2019 |
| K962680 | HYUNJAE CORP. | HYUNJAE DENTAL IMPRESSION MATERIALS | 09/30/1996 |
| K213890 | IMICRYL Dis Malzemeleri San. Ve Tic. A.S. | IMICRYL Impression Materials | 02/11/2022 |
| K223892 | Innovative Product Brands, Inc. | DentMix VPS Impression Material | 04/27/2023 |
| K103586 | IOS TECHNNOLOGIES, INC. | IOS FASTSCAN SPRAY | 03/30/2011 |
| K143575 | IVOCLAR VIVADENT, INC. | Accu-Dent XD Tray, Accu-Dent XD Syringe | 04/03/2015 |
| K060891 | IVOCLAR VIVADENT, INC. | VIRTUAL | 07/17/2006 |
| K964692 | J. MORITA USA, INC. | PERFECTIM | 02/25/1997 |
| K001218 | JENERIC/PENTRON, INC. | CORRECT PLUS | 07/05/2000 |
| 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 |
| 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 |
| 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 |
| K201184 | Lascod Spa | Lascod Impression Materials | 05/05/2020 |
| 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 |
| 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 |
| K211489 | Nanchang Dental Bright Technology Co., Ltd | Dental Impression Material | 07/28/2021 |
| K152180 | Neosil Co., Ltd | PEAK | 10/22/2015 |
| K180565 | Neosil Co., Ltd | PEAK NS033CF, PEAK NS017CF | 06/13/2018 |
| K213175 | No Stress Impress LLC | No Stress Impress | 01/19/2023 |
| K964177 | NORTH AMERICAN ORTHODONTIC LABORATORIES, INC. | KROMALGIN IMPRESSION MATERIAL | 12/30/1996 |
| K011450 | NORTHEAST RESINS & SILICONES, LLC. | SILICONE IMPRESSION MATERIAL | 06/13/2001 |
| 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 |
| K210041 | Osstem Implant Co., Ltd. | HySil Plus Impression Materials | 03/18/2021 |
| K192941 | Osstem Implant Co., Ltd. | HySil Super Fast Impression Materials | 01/30/2020 |
| 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 |
| K962741 | PARKELL, INC. | TRI-PHASIX CHROMATIC ALGINATE | 09/06/1996 |
| K130920 | PENTRON CLINICAL | CORRECT PLUS 1 | 07/02/2013 |
| K120013 | PENTRON CLINICAL | TEMPSPAN CLEAR MATRIX | 05/22/2012 |
| K213244 | Prevest Denpro Limited | Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) | 09/09/2022 |
| K001414 | R-DENTAL DENTALERZEUGNISSE GMBH | KWIKKMODEL | 08/09/2000 |
| K010926 | R-DENTAL DENTALERZEUGNISSE GMBH | R-SI-LINE METAL-BITE | 04/12/2001 |
| 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 |
| 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 |
| 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 |
| K143382 | SeilGlobal Co., Ltd. | DentiAnn Smart Sil | 02/23/2015 |
| K032708 | SEPTODONT | PLASTALGIN AND PLASTALGIN ORTHO | 11/20/2003 |
| K201684 | Shandong Huge Dental Material Corporation | A-Silicone for Bite Registration | 09/24/2020 |
| 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 |
| 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 |
| 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 |
| 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 |
| K970594 | TELEDYNE WATER PIK | KALGINATE IMPRESSION MATERIAL | 03/31/1997 |
| 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 |
| 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 |
| K201483 | Zhengzhou Huaer Electro Optics Technology Co., Ltd | Impression Material | 10/08/2020 |
| 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 |
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