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 |
| K182422 | Dentsply Sirona | Lucitone Denture Base Materials | 12/18/2018 |
| 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 |
| K181331 | Juvora, Ltd. | JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White | 12/21/2018 |
| 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 |
| K821217 | OKI SHIKS USA LTD. | REIGNING DENTURE | 06/07/1982 |
| K802490 | OKI SHIKS USA LTD. | REIGNING DENTURE | 11/19/1980 |
| 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 |
| K181220 | Park Dental Research Corporation | Juell 3D Volo Base | 10/12/2018 |
| 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 |
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