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 |
| K230115 | Aidite (Qinhuangdao) Technology Co., Ltd | Denture Base Resin | 03/17/2023 |
| K082180 | ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS | PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 | 12/17/2008 |
| K021121 | AROMACRYL, LLC | AROMACRYL | 05/28/2002 |
| K970522 | AUSTENAL, INC. | MYERSON'S ECONOMY DENTURE BASE MATERIAL | 05/14/1997 |
| 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 |
| 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 |
| K170375 | CMP Industries LLC | Nobilplast Denture Resin | 10/02/2017 |
| K072402 | CMP INDUSTRIES LLC. | FLEX-STAR V | 10/19/2007 |
| K033020 | CMP INDUSTRIES LLC. | IMPAK ACRYLIC REPAIR RESIN LIQUID | 12/19/2003 |
| K072851 | CMP INDUSTRIES LLC. | POLYSTAR 79 DENTURE BASE RESIN | 02/20/2008 |
| K081537 | COMFORT AND FLEXIBLE SYSTEMS | CFS FLEXIBLE | 01/22/2009 |
| K063626 | COSMETIC DENTAL MATERIALS INC | DURAFLEX | 02/08/2007 |
| 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 |
| K212541 | DeltaMed GmbH | 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix | 01/10/2022 |
| K230341 | DeltaMed GmbH | ACRIFIX | 04/06/2023 |
| 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 |
| K230410 | Dental Direkt GmbH | DD medical polymers (PMMA) | 06/23/2023 |
| 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 |
| K220042 | Dentca, Inc. | Dentca Base Premium, Dentca Base Hi-Impact | 11/17/2022 |
| 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 |
| K972573 | DENTSPLY INTL. | LIQCRYLIC PRO DENTAL RESIN | 09/16/1997 |
| K992956 | DENTSPLY INTL. | LUCITONE FRS FLEXIBEL DENTAL RESIN | 10/06/1999 |
| K032892 | DENTSPLY INTL. | MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM | 09/26/2003 |
| K011560 | DENTSPLY INTL. | TRUBYTE DENTURE BASE RESIN SYSTEM | 07/12/2001 |
| K964040 | DENTSPLY INTL. | TRUBYTE SOFT RELINE SYSTEM | 12/06/1996 |
| K190043 | Dentsply Sirona | Halley resin | 04/24/2019 |
| K191427 | Dentsply Sirona | Halley resin system | 08/26/2019 |
| K182422 | Dentsply Sirona | Lucitone Denture Base Materials | 12/18/2018 |
| K161330 | Dentsply Sirona | Pour Acrylic | 10/06/2016 |
| K200461 | Detax GmbH & Co. KG | Freeprint denture | 11/16/2020 |
| K162654 | DETAX GmbH & Co.KG | mollosil plus | 03/13/2017 |
| K193623 | DIO Corporation | DIOnavi-Denture | 10/22/2020 |
| K210828 | DIO Corporation | DIOnavi-Denture02 | 03/23/2021 |
| K190790 | DK Mungyo Corporation | Flex Fit | 07/31/2020 |
| K200580 | Dreve Dentamid GmbH | FotoDent denture | 11/19/2020 |
| K191591 | Enlighten Materials Co., Ltd | BB Base 3D printing resin for denture base | 08/18/2020 |
| K203641 | EnvisionTEC GmbH | E-Denture Pro | 03/30/2021 |
| K991220 | ESPE DENTAL AG | VITRON H | 05/20/1999 |
| K990763 | ESPE DENTAL AG | VITRON M | 05/25/1999 |
| 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 |
| 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 |
| K051358 | GC AMERICA, INC. | NATURE-CRYL HI PLUS | 07/07/2005 |
| K061735 | GLOBAL DENTAL PRODUCTS, INC. | INFIBRA, MODEL 1200 | 09/08/2006 |
| K153590 | Global Dental Science | AvaDent Denture Base Material | 04/22/2016 |
| K222414 | Graphy Inc. | TERA HARZ DENTURE | 08/11/2022 |
| K083479 | GREAT LAKES ORTHODONTICS, LTD. | BIOCRYL X | 02/27/2009 |
| K040881 | GREAT LAKES ORTHODONTICS, LTD. | METACRYL | 05/25/2004 |
| K033632 | GREAT LAKES ORTHODONTICS, LTD. | VARIFLEX | 01/21/2004 |
| K961200 | HARRY J. BOSWORTH CO. | BOSWORTH LIQUID RESIN II | 05/17/1996 |
| 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 |
| K231389 | Harvest Dental Products, LLC | Harvest Dental HD Gum Strip | 08/16/2023 |
| K222489 | Harvest Dental Products, LLC | Harvest Printable Resin | 05/12/2023 |
| K043504 | HERAEUS KULZER, INC. | PALAIMPACT | 01/28/2005 |
| 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 |
| K103391 | IVOCLAR VIVADENT, INC. | IVOBASE HYBRID, IVOBASE HIGH IMPACT | 02/17/2011 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K230098 | Myerson, LLC | TrusanaÖ | 04/13/2023 |
| 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 |
| K113608 | NUXEN S.R.L. | DEFLEX | 04/10/2012 |
| K113788 | NUXEN S.R.L. | DEFLEX ACRILATO | 03/16/2012 |
| K210189 | Pac-Dent, Inc. | Pac-Dent Denture Base Resin | 07/28/2021 |
| K181220 | Park Dental Research Corporation | Juell 3D Volo Base | 10/12/2018 |
| K974865 | PARKELL, INC. | CSR | 03/16/1998 |
| K053516 | PARKELL, INC. | MUCOHARD | 01/26/2006 |
| 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 |
| K973542 | PRESSING DI MONTICELLI RAG. STEFANO | MASKY | 02/10/1998 |
| K213765 | Prismatik Dentalcraft, Inc. | Glidewell 3DP Denture Base Resin | 06/22/2022 |
| K210298 | Pro3dure Medical GmbH | GR-14 Resin System | 05/05/2021 |
| K151646 | PROTECH PROFESSIONAL PRODUCTS, INC. | ProTech Plus | 10/21/2015 |
| K983547 | PROTECH, INC. | PROTECH PLUS | 01/07/1999 |
| K072479 | RAPID INJECTION SYSTEMS CORP. | FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD | 11/09/2007 |
| K122348 | RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) | QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW | 10/15/2012 |
| K013881 | RIBBOND, INC. | RIBBOND - TRIAXIAL | 01/25/2002 |
| 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 |
| K220680 | Shandong Huge Dental Material Corporation | Denture Base Polymers | 08/12/2022 |
| K213994 | Shandong Huge Dental Material Corporation | Flexible Block | 03/04/2022 |
| K073040 | SMH BIOMATERIAL AG | SMH FLEX S | 12/13/2007 |
| K220979 | SprintRay Inc | SprintRay Denture Base | 09/14/2022 |
| K230445 | SprintRay Inc. | OnX Tough | 07/14/2023 |
| K221678 | SprintRay Inc. | SprintRay High Impact Denture Base | 11/10/2022 |
| K992176 | ST. GEORGE TECHNOLOGY, INC. | EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL | 02/10/2000 |
| 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 |
| K220771 | Stratasys Ltd | Stratasys TrueDent | 07/07/2022 |
| 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 |
| 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 |
| 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 |
| 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 |
| K190940 | Tokuyama Dental Corporation | Tokuyama Rebase III | 10/04/2019 |
| 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 |
| K191497 | Vertex-Dental BV | NextDent Denture 3D+ | 11/01/2019 |
| K162572 | VERTEX-DENTAL BV | NextDent Denture, E-Denture | 06/30/2017 |
| K962333 | VIDENT | V.R.S. DENTURE RESIN MATERIAL | 08/07/1996 |
| K191926 | VITA Zanhnfabrik H. Rauter GmbH Co. | VITA VIONIC Bond | 01/29/2020 |
| K220743 | VOCO GmbH | CediTEC | 07/05/2022 |
| 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 |
| K220236 | Voco GmbH | V-Print dentbase | 09/21/2022 |
| 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 |
| 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 |
| K232691 | Zirkonzahn Srl | Polibond | 09/05/2023 |
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