FDA 510(k) Applications for Medical Device Product Code "EBI"
(Resin, Denture, Relining, Repairing, Rebasing)

FDA 510(k) Number Applicant Device Name Decision Date
K061501 ACI, INC. FLEXO DENTAL RESIN MATERIAL 07/26/2006
K954637 AMERICAN DENTAL PRODUCTS, INC. AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER 12/28/1995
K884751 AMERICAN MFG., INC. DANSU PERMANENT CHAIR SOFT LINER 01/27/1989
K884865 AMERICAN MFG., INC. PERMASEAL AND DENTURE SEAL 01/30/1989
K895714 AMERICAN ORTHODONTICS ORTHO-KEV APPLIANCE REINFORCING SYSTEM 12/21/1989
K082180 ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 12/17/2008
K021121 AROMACRYL, LLC AROMACRYL 05/28/2002
K874025 ASTRON DENTAL CORP. 2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN 12/23/1987
K833270 ASTRON DENTAL CORP. ASTRON 77 INJECTION DENTURE RESIN 07/19/1984
K864757 ASTRON DENTAL CORP. MODIFIED VINYLAC PRESS PACK DENTURE RESIN 02/10/1987
K831269 ASTRON DENTAL CORP. VINYLAC PRESS-PACK DENTURE RESIN 06/08/1983
K863630 AUSTENAL DENTAL, INC. AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL 03/11/1987
K862558 AUSTENAL DENTAL, INC. AUSTENAL ACUPAC HI DENTURE BASE MATERIAL 07/18/1986
K862557 AUSTENAL DENTAL, INC. AUSTENAL ACUSOFT SOFT LINER 02/19/1987
K883799 AUSTENAL DENTAL, INC. BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN 10/20/1988
K871849 AUSTENAL DENTAL, INC. LIGHT CURE DENTURE GLAZE 08/10/1987
K954810 AUSTENAL, INC. MYERSON IR DENTURE BASE 11/29/1995
K970522 AUSTENAL, INC. MYERSON'S ECONOMY DENTURE BASE MATERIAL 05/14/1997
K933468 AUSTENAL, INC. MYERSON'S PERMASOFT SOFT RELINE MATERIAL 01/05/1994
K871038 B. L. DENTAL CO. LUTEMOLL (BIOPLAST) 05/19/1987
K871312 BIOMEDICAL COMPOSITES, LTD. FIBREFLEX 04/15/1987
K001640 BIOSOFT INTERNATIONAL CORP. BIOSOFT RESIN 06/23/2000
K141439 BISCO, INC. ORTHODONTIC ACRYLIC (NOT FINALIZED) 09/12/2014
K034024 BISCO, INC. TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS 03/19/2004
K033472 BISCO, INC. TESCERA U-BAR AND BARRELS 01/15/2004
K953119 BOSWORTH CO. BOSWORTH RESIN II 08/28/1995
K810094 BOSWORTH CO. DENTURE RUBBER BASE MATERIAL 02/02/1981
K991687 BOSWORTH CO. MODIFICATION TO LINER II: SOFT RELINE LIQUID 10/07/1999
K052780 BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT DENTAPLAST HOT, MODEL 16-XXX 12/21/2005
K974160 BRUXCARE, L.L.C. BRUXTRAK MATERIAL 03/11/1998
K881245 CADCO DENTAL PRODUCTS, INC. DENT-URE LINER SOFT RESILIENT DENTURE LINING MATER 07/21/1988
K170375 CMP Industries LLC Nobilplast Denture Resin 10/02/2017
K072402 CMP INDUSTRIES LLC. FLEX-STAR V 10/19/2007
K902972 CMP INDUSTRIES LLC. FLEXOR (DENTURE ACRYLIC RELINE MATERIAL) 10/04/1990
K033020 CMP INDUSTRIES LLC. IMPAK ACRYLIC REPAIR RESIN LIQUID 12/19/2003
K072851 CMP INDUSTRIES LLC. POLYSTAR 79 DENTURE BASE RESIN 02/20/2008
K792427 COE LABORATORIES, INC. PERMA-CRYL 20 12/13/1979
K820673 COE LABORATORIES, INC. SELF-CURING HARD DENTURE LINER 04/09/1982
K850650 COLE POLYMERS LTD. DENTAL ACRYLIC POLYMERS 05/22/1985
K910795 COMFORT ACRYLICS CO. COMFOR-DENT DENTURE LINER 07/11/1991
K900799 COMFORT ACRYLICS CO. COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS 05/15/1990
K081537 COMFORT AND FLEXIBLE SYSTEMS CFS FLEXIBLE 01/22/2009
K063626 COSMETIC DENTAL MATERIALS INC DURAFLEX 02/08/2007
K842476 CREDENT CO. CREDENT RADIOPAQUE CROWN & BRIDE 12/03/1984
K842477 CREDENT CO. CREDENT RADIOPAQUE DENTURE RESIN 12/03/1984
K993717 DAVIS SCHOTTLANDER & DAVIS, LTD. ENIGMA HI-BASE DENTURE BASE MATERIAL 12/22/1999
K001463 DAVIS SCHOTTLANDER & DAVIS, LTD. SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 06/16/2000
K011762 DENPLUS, INC. HI-WAVE; POUR-PLUS 08/23/2001
K991996 DENPLUS, INC. IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR 09/08/1999
K901621 DENTAL PRODUCT CO. NEW PER-FIT(R) IMPROVED 06/26/1990
K160498 Dental Solutions, LLC Dentivera Milling Disc 06/15/2016
K990448 DENTAMAX, INC. THE.R.MO.FREE 03/23/1999
K042931 DENTATUS USA, LTD. TUF LINK SILICONE RELINER 12/08/2004
K143033 DENTCA, INC. DENTCA DENTURE BASE 07/21/2015
K162044 DENTCA, Inc. Dentca Denture Base II 03/03/2017
K130680 DENTSOLL, INC. ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS 07/26/2013
K061580 DENTSPLY INTERNATIONAL ECLIPSE WAX REMOVER 07/28/2006
K072713 DENTSPLY INTERNATIONAL, INC. ION DENTAL RESIN SYSTEM 10/12/2007
K834409 DENTSPLY INTL. DENTURE BASE RESIN 02/27/1984
K792042 DENTSPLY INTL. DENTURE BASE RESIN 11/30/1979
K780786 DENTSPLY INTL. DENTURE RELINE MATERIAL 06/14/1978
K831647 DENTSPLY INTL. DENTURE RELINING, REPAIR/REBASING RESIN 06/30/1983
K926406 DENTSPLY INTL. DUAL CURE RELINE MATERIAL 03/31/1993
K051707 DENTSPLY INTL. ECLIPSE BONDING AGENT 07/15/2005
K972573 DENTSPLY INTL. LIQCRYLIC PRO DENTAL RESIN 09/16/1997
K895742 DENTSPLY INTL. LITELINE VLC SOFT RELINE 12/18/1989
K992956 DENTSPLY INTL. LUCITONE FRS FLEXIBEL DENTAL RESIN 10/06/1999
K800400 DENTSPLY INTL. MAXUM DENTURE RESIN 03/12/1980
K032892 DENTSPLY INTL. MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM 09/26/2003
K905702 DENTSPLY INTL. NEW TRIAD TRANSHEET DENTURE BASE MATERIAL 04/29/1991
K952351 DENTSPLY INTL. PRECISE DENTURE BASE RESIN 07/07/1995
K863324 DENTSPLY INTL. TRIAD IMPACT 09/05/1986
K882482 DENTSPLY INTL. TRIAD ORTHODONTIC GEL 08/12/1988
K011560 DENTSPLY INTL. TRUBYTE DENTURE BASE RESIN SYSTEM 07/12/2001
K964040 DENTSPLY INTL. TRUBYTE SOFT RELINE SYSTEM 12/06/1996
K161330 Dentsply Sirona Pour Acrylic 10/06/2016
K162654 DETAX GmbH & Co.KG mollosil plus 03/13/2017
K873738 E&D DENTAL MANUFACTURING CO. ACRYLIC BASE DENTURE MATERIALS 11/20/1987
K991220 ESPE DENTAL AG VITRON H 05/20/1999
K990763 ESPE DENTAL AG VITRON M 05/25/1999
K800458 EUROPEAN ORTHODONTIC PRODUCTS ORTHODONTICARTIDE 03/25/1980
K831095 FACTOR, II, INC. ROYALE II 08/31/1983
K890830 G-C INTL. CORP. DENTURE RESIN 05/01/1989
K991774 GC AMERICA, INC. ACRON MC MODIFICATION 07/09/1999
K070698 GC AMERICA, INC. COE COMFORT 03/29/2007
K070697 GC AMERICA, INC. COE SOFT 03/29/2007
K940565 GC AMERICA, INC. COE-SOFT LC 05/04/1994
K963144 GC AMERICA, INC. GC BASELINE 10/29/1996
K982695 GC AMERICA, INC. GC RELINE 10/19/1998
K153253 GC AMERICA, INC. GC Reline II 03/03/2016
K990736 GC AMERICA, INC. GC RELINE SOFT/EXTRA SOFT 05/28/1999
K984365 GC AMERICA, INC. GC UNIFAST TRAD 02/25/1999
K935261 GC AMERICA, INC. KOOLINER II 01/26/1994
K051358 GC AMERICA, INC. NATURE-CRYL HI PLUS 07/07/2005
K930939 GC AMERICA, INC. REBARON LC 01/21/1994
K823568 GENERAL DENTAL PRODUCTS, INC. POLY-TONE DENTURE BASE RESIN 01/12/1983
K061735 GLOBAL DENTAL PRODUCTS, INC. INFIBRA, MODEL 1200 09/08/2006
K153590 Global Dental Science AvaDent Denture Base Material 04/22/2016
K083479 GREAT LAKES ORTHODONTICS, LTD. BIOCRYL X 02/27/2009
K040881 GREAT LAKES ORTHODONTICS, LTD. METACRYL 05/25/2004
K925275 GREAT LAKES ORTHODONTICS, LTD. SOFT DENTURE RELINE MATERIAL ELASTOLINE 01/11/1993
K870908 GREAT LAKES ORTHODONTICS, LTD. STEADY RESIN 03/19/1987
K033632 GREAT LAKES ORTHODONTICS, LTD. VARIFLEX 01/21/2004
K871497 GULF SOUTH RESEARCH INSTITUTE LINER OR GSRI-PNF 06/17/1987
K840405 HARRY J. BOSWORTH CO. BOSWORTH DENT-ALL 05/01/1984
K961200 HARRY J. BOSWORTH CO. BOSWORTH LIQUID RESIN II 05/17/1996
K842576 HARRY J. BOSWORTH CO. CLEAR LINER 09/27/1984
K946317 HARRY J. BOSWORTH CO. HARRY J. BOSWORTH RESIN I. 02/16/1995
K981861 HARRY J. BOSWORTH CO. LINER 1:HARD RELINE LIQUID 10/01/1998
K990699 HARRY J. BOSWORTH CO. ORTHO-GLOW GLITTER 05/17/1999
K981862 HARRY J. BOSWORTH CO. RESIN 4 02/09/1999
K981691 HARRY J. BOSWORTH CO. SILICONE SOFT RELINE 11/03/1998
K913698 HERAEUS KULZER, INC. ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL 10/09/1991
K910465 HERAEUS KULZER, INC. MELIODENT, DENTURE RESIN 06/06/1991
K913699 HERAEUS KULZER, INC. MODERN MATERIALS ORTHODONTIC RESIN 10/09/1991
K924422 HERAEUS KULZER, INC. PALABOND 11/04/1992
K915898 HERAEUS KULZER, INC. PALADUR 09/16/1992
K043504 HERAEUS KULZER, INC. PALAIMPACT 01/28/2005
K953743 HERAEUS KULZER, INC. PALASPLINT 10/02/1995
K961995 HERAEUS KULZER, INC. QUICKSPLINT 06/26/1996
K033629 HERAEUS KULZER, INC. VERSYO.BOND 12/22/2003
K010800 HERAEUS KULZER, INC. VERSYO.COM 05/31/2001
K043295 HERAEUS KULZER, INC. VERSYO.DIRECT 01/05/2005
K111832 HERAEUS KULZER, LLC PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID 09/29/2011
K110037 HERAEUS KULZER, LLC PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID 04/29/2011
K021586 IMTEC CORP. SECURE RELINE/PICKUP MATERIAL 06/14/2002
K021437 IMTEC CORP. SECURE SOFT 07/19/2002
K913655 IVOCLAR NORTH AMERICA, INC. PROBASE HOT AND PROBASE COLD 10/17/1991
K896130 IVOCLAR NORTH AMERICA, INC. SR-IVOCAP 04/16/1990
K915377 IVOCLAR NORTH AMERICA, INC. SR-IVOCAP PLUS 01/31/1992
K896139 IVOCLAR NORTH AMERICA, INC. SR-IVOSEAL 04/16/1990
K864709 IVOCLAR USA, INC. IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL 02/10/1987
K864708 IVOCLAR USA, INC. SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN 02/25/1987
K103391 IVOCLAR VIVADENT, INC. IVOBASE HYBRID, IVOBASE HIGH IMPACT 02/17/2011
K810687 J. ADERER, INC. SR-IVOCAP 04/14/1981
K060844 J. MORITA USA, INC. SILKLINE SOFT RELINING KIT, MODEL 28-100100 06/06/2006
K002048 J.B.C AND CO. JBC OPAQUE AND GLITTER 08/30/2000
K974727 J.B.C AND CO. JET ACRYLIC LIQUID-MONOMER, ORTHO JET POWDER-POLYMER, PLASTICIZED METHACRYLATE HOMOPOLYMER, METHACRYLATE COPOLYMER, METR 02/24/1998
K990056 J.F. JELENKO & CO., INC. JELDENT MULTICRYL 03/25/1999
K953381 JENERIC/PENTRON, INC. PROP. CONQUEST C&B VLC GLAZE/SEALANT 09/27/1995
K111177 JUELL DENTAL JUELL HARD CURE 09/12/2011
K111178 JUELL DENTAL JUELL SOFT CURE 09/12/2011
K160918 JUVORA JUVORA Dental Disc, Ceramill PEEK by JUVORA 02/13/2017
K132725 JUVORA JUVORA DENTQAL DISC 01/23/2014
K992609 KAY SEE DENTAL MFG. CO. HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 09/22/1999
K942562 KNOPF ASSOC, INC. PROSTHOFLEX 12/20/1994
K980616 KOHLER MEDIZINTECHNIK GMBH & CO. KG PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15) 04/30/1998
K152270 KOREA ENGINEERING PLASTICS CO., LTD. Denture base resin 11/13/2015
K901789 KULZER, INC. PALADON(R) 65 06/22/1990
K902115 KULZER, INC. PALAPRESS(R) VARIO RESIN 07/27/1990
K892452 KULZER, INC. PALASEAL(R) 06/16/1989
K163482 Lang Dental Manufacturing Co., Inc. Orthodontic Acrylic 2 05/31/2017
K152981 LANG DENTAL MANUFACTURING COMPANY, INC JET SET 4 DENTURE REPAIR RESIN 09/02/2016
K072580 LANG DENTAL MFG. CO., INC. JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23 11/05/2007
K100653 LANG DENTAL MFG. CO., INC. JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD 10/08/2010
K081981 LANG DENTAL MFG. CO., INC. LANG DENTAL ACRYLIC PRIMER 11/17/2008
K972553 LANG DENTAL MFG. CO., INC. LANG DENTAL RESIN A97 FIBRED PINK 11/13/1997
K941925 LANG DENTAL MFG. CO., INC. ORTHO-JET ACRYLIC RESIN - SPARKLE 05/27/1994
K112397 LANG DENTAL MFG. CO., INC. ORTHO-JET CRYSTAL 11/04/2011
K081514 LANG DENTAL MFG. CO., INC. TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER 09/22/2008
K081884 MAJOR PRODOTTI DENTARI S.P.A. MAJOR.BASE 20 10/08/2008
K082153 MAJOR PRODOTTI DENTARI S.P.A. MAJOR.REPAIR 11/25/2008
K991577 MANUFACTURERA DENTAL CONTINENTAL NIC TONE ACRYLIC RESINS 09/22/1999
K140758 MERZ DENTAL GMBH M-PM-DISC (PINK) 09/15/2014
K130076 MERZ DENTAL GMBH PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS 08/22/2013
K063170 MICERIUM S.P.A. TENDER FIBER 01/12/2007
K984467 MICRO DENTAL LABORATORIES FUSICRYL 02/24/1999
K032773 MYCONE DENTAL SUPPLY CO., INC. DIAMOND D HIGH IMPACT DENTURE ACRYLIC 09/23/2003
K983876 MYCONE DENTAL SUPPLY CO., INC. (A/K/A KEYSTONE IND MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC 12/16/1998
K152051 Mycone Dental Supply Co., t/a Keystone Industries ClearMet 03/22/2016
K172764 Mycone Dental Supply Company, Inc. (aka Keystone Industries) Keymill 04/27/2018
K011820 NATS CORP. DENTORIUM CONVERTIBLE ACRYLIC 09/05/2001
K102874 NEW STETIC NEW STETIC ACRYLICS 03/28/2011
K031070 NOBEL BIOCARE AB CARBON FIBER BRIDGE, MODEL 28757 07/03/2003
K933831 NU-DENT, INC. PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC. 12/06/1993
K113608 NUXEN S.R.L. DEFLEX 04/10/2012
K113788 NUXEN S.R.L. DEFLEX ACRILATO 03/16/2012
K802490 OKI SHIKS USA LTD. REIGNING DENTURE 11/19/1980
K821217 OKI SHIKS USA LTD. REIGNING DENTURE 06/07/1982
K801234 OKI SHIKS USA LTD. REIGNING DENTURE MADE OF POLYCARB. RESIN 06/09/1980
K802491 OKI SHIKS USA LTD. REIGNING REPAIR EPOXY RESIN 11/12/1980
K896719 PARKELL PRIMER-P ADHESIVE AGENT 02/22/1990
K974865 PARKELL, INC. CSR 03/16/1998
K053516 PARKELL, INC. MUCOHARD 01/26/2006
K861239 PARKER LABORATORIES, INC. ACRYLIC SOLDER 04/17/1986
K840548 PARKER LABORATORIES, INC. RESIL 04/17/1984
K150454 PERFLEX Acryfree Denture Base Material and Biosens Denture Base Material 05/26/2015
K153546 POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY PINK CAD/CAM disc 09/28/2016
K962374 POLYDENTIA USA FIBER-SPLINT ML MULTILAYER 07/22/1996
K790325 PREMIER DENTAL PRODUCTS CO. REPRODENT 03/02/1979
K973542 PRESSING DI MONTICELLI RAG. STEFANO MASKY 02/10/1998
K943905 PROFESSIONAL POSITIONERS, INC. PRO-CRYLIC RESIN, TECHNICOLOR PRE-MIX MONOMER 02/27/1995
K925062 PROTECH PROFESSIONAL PRODUCTS, INC. PERMAFLEX PERMANENT SOFT DENTURE RELINER 03/31/1993
K151646 PROTECH PROFESSIONAL PRODUCTS, INC. ProTech Plus 10/21/2015
K983547 PROTECH, INC. PROTECH PLUS 01/07/1999
K853094 PSP DENTAL CO., LTD. EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA 04/04/1986
K072479 RAPID INJECTION SYSTEMS CORP. FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD 11/09/2007
K810869 RAPID INJECTION SYSTEMS CORP. SILICONE ELASTOMER KIT 04/29/1981
K122348 RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW 10/15/2012
K852741 RELIANCE DENTAL MFG. CO. DURA CONDITIONER 09/23/1985
K870148 RELIANCE DENTAL MFG. CO. DURA ORTHO ACRYLIC 02/19/1987
K894564 RELIANCE ORTHODONTIC PRODUCTS, INC. RELIANCE LIGHT CURE RETAINER ACRYLIC 10/17/1989
K013881 RIBBOND, INC. RIBBOND - TRIAXIAL 01/25/2002
K913040 RIBBOND, INC. RIBBOND(TM) 10/07/1991
K834435 ROHM AND HAAS CO. CROWN & BRIDGE RESIN 02/21/1984
K983357 ROYDENT DENTAL PRODUCTS, INC. MUCOPREN SOFT RELINING SYSTEM 11/13/1998
K984483 S & C POLYMER GMBH A-SOFT RELINER 02/18/1999
K011277 S & C POLYMER GMBH HARD RELINER 06/26/2001
K053328 SATELEC BIOSPLINT SPLINTING RIBBON 01/25/2006
K052073 SCHUTZ-DENTAL GMBH FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000 10/26/2005
K895222 SCIENTIFIC PHARMACEUTICALS, INC. CURAY-FORM 10/24/1989
K944466 SCIENTIFIC PHARMACEUTICALS, INC. SEALDENT 03/02/1995
K073040 SMH BIOMATERIAL AG SMH FLEX S 12/13/2007
K934019 ST. GEORGE TECHNOLOGY, INC. EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO 01/18/1994
K992176 ST. GEORGE TECHNOLOGY, INC. EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL 02/10/2000
K945711 ST. GEORGE TECHNOLOGY, INC. EXCEL-P FORMULA AUTO-CURE DENTURE BASE 02/02/1995
K984341 STERNGOLD/IMPLAMED STERNVANTAGE VARNISH LC, MODEL 221001 01/08/1999
K011788 STICK TECH LTD. EVERSTICK 11/05/2001
K021126 STICK TECH LTD. EVERSTICK ORTHO 05/13/2002
K030072 STICK TECH LTD. EVERSTICK PERIO 04/10/2003
K011799 STICK TECH LTD. EVERSTICKNET 11/05/2001
K003333 STICK TECH LTD. STICK 01/04/2001
K003334 STICK TECH LTD. STICK NET 01/08/2001
K971138 SULTAN CHEMISTS, INC. DINABASE (TM) 07/21/1997
K150511 SUN MEDICAL CO., LTD Coating Material 05/27/2015
K143265 SUN MEDICAL CO., LTD. Acrylic Block 04/14/2015
K954689 SYBRON DENTAL SPECIALTIES, INC. CONNECT 10/30/1995
K981448 SYBRON DENTAL SPECIALTIES, INC. KERR HARD DENTURE RELINE MATERIAL 06/16/1998
K963736 SYBRON DENTAL SPECIALTIES, INC. SOFT DENTURE REBASING RESIN 12/04/1996
K102207 SYNCA MARKETING, INC. FIBER FORCE 11/23/2010
K071245 TALON ACRYLICS, INC. TALON AND REVERE 08/02/2007
K821230 THE HEALTHCARE GROUP LABORATORIES, INC. SOFTIC 49 05/28/1982
K900301 THE HYGENIC CORP. NOVUS BONDING AGENT 05/15/1990
K172407 The Myerson Company Limited Duracetal 11/02/2017
K012882 THERMOELASTIC TECHNOLOGIES, INC. BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060 11/14/2001
K123396 THERMOPLASTIC COMFORT SYSTEMS, INC. I.FLEX BY TCS 01/10/2013
K142894 Thermoplastic Comfort Systems, Inc. TCS Blend 02/03/2015
K053060 THERMOPLASTIC COMFORT SYSTEMS, INC. TCS UNBREAKABLE 07/20/2006
K896980 TOKUYAMA AMERICA, INC. PALFIQUE LIGHT LINER 05/15/1990
K896981 TOKUYAMA AMERICA, INC. TOKUSO REBASE 05/15/1990
K022641 TOKUYAMA AMERICA, INC. TOKUYAMA REBASE II 10/02/2002
K982537 TOKUYAMA AMERICA, INC. TOKUYAMA SOFRELINER 08/24/1998
K953589 TOKUYAMA AMERICA, INC. TOKUYAMA SOFT RELINING 01/18/1996
K112445 TOKUYAMA DENTAL CORPORATION SOFRELINER TOUGH S 10/28/2011
K170549 Tokuyama Dental Corporation TOKUYAMA CUREGRACE 07/05/2017
K030663 TOKUYAMA DENTAL CORPORATION TOKUYAMA SOFRELINER TOUGH 05/29/2003
K081554 TOKUYAMA DENTAL CORPORATION TOKUYAMA TISSUECARE 03/18/2009
K983461 TRANS-ATLANTIC DENTAL UNI-FLEX RESIN 04/13/1999
K111709 UNIX-JAPAN CO., LTD. FOUNDATION DENTAL RESIN 11/18/2011
K102654 VERTEX-DENTAL B.V. VERTEX RAPID SIMPLIFIED 12/03/2010
K102640 VERTEX-DENTAL B.V. VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS 03/25/2011
K123220 VERTEX-DENTAL B.V. VERTEX THERMOSENS RIGID 03/01/2013
K162572 VERTEX-DENTAL BV NextDent Denture, E-Denture 06/30/2017
K962333 VIDENT V.R.S. DENTURE RESIN MATERIAL 08/07/1996
K102347 VOCO GMBH GRANDTEC 10/29/2010
K110440 VOCO GMBH QUICK UP 05/04/2011
K974772 VOCO GMBH UFI GEL C 02/10/1998
K993827 VOCO GMBH UFI GEL HARD 01/20/2000
K143486 VOCO GMBH Ufi Gel hard C 01/07/2015
K030916 VOCO GMBH UFI GEL HARD C 06/19/2003
K934248 WALLACE A. ERICKSON & CO. ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER 12/08/1993
K140146 WHIP MIX CORP. COMFORTSOFT SOFT DENTURE LINER SYSTEM 04/29/2014
K151142 WIELAND DENTAL + TECHNIK GMBH & CO. KG IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID 08/13/2015
K912990 WILDE-USA, INC. CONVERBASE 03/25/1992
K920557 WILDE-USA, INC. WIL-O-DONT ORTHODONTIC MATERIAL/WIL-O-LUX 03/20/1992
K912991 WILDE-USA, INC. WILDE AUXILIARIES 12/19/1991
K912993 WILDE-USA, INC. WILDE DENTURE RESINS 02/03/1992
K131036 YAMAHACHI DENTAL MANUFACTURING CO. YAMAHACHI DENTURE BASE RESINS 07/12/2013
K172683 Yamahachi Dental Mfg., Co. Yamahachi Pink CAD/CAM Disk 01/16/2018
K140570 ZEST ANCHORS, LLC CHAIRSIDE ATTACHMENT PROCESSING MATERIAL 06/16/2014


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