FDA Product Code
FDA Product Code EBI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3760
510(k) Clearances — 335 records · page 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K123220 | VERTEX THERMOSENS RIGID | Vertex-Dental B.V. | 2013-03-01 | Traditional | PDF ↗ |
| K123396 | I.FLEX BY TCS | Thermoplastic Comfort Systems, Inc. | 2013-01-10 | Traditional | PDF ↗ |
| K122348 | QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW | Recherches Techniques Dentaires (R.T.D.) | 2012-10-15 | Traditional | PDF ↗ |
| K113608 | DEFLEX | Nuxen S.R.L. | 2012-04-10 | Traditional | PDF ↗ |
| K113788 | DEFLEX ACRILATO | Nuxen S.R.L. | 2012-03-16 | Traditional | PDF ↗ |
| K111709 | FOUNDATION DENTAL RESIN | Unix-Japan Co., Ltd. | 2011-11-18 | Traditional | PDF ↗ |
| K112397 | ORTHO-JET CRYSTAL | Lang Dental Mfg. Co., Inc. | 2011-11-04 | Traditional | PDF ↗ |
| K112445 | SOFRELINER TOUGH S | Tokuyama Dental Corporation | 2011-10-28 | Traditional | PDF ↗ |
| K111832 | PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID | Heraeus Kulzer, LLC | 2011-09-29 | Traditional | PDF ↗ |
| K111178 | JUELL SOFT CURE | Juell Dental | 2011-09-12 | Traditional | PDF ↗ |
| K111177 | JUELL HARD CURE | Juell Dental | 2011-09-12 | Traditional | PDF ↗ |
| K110440 | QUICK UP | Voco GmbH | 2011-05-04 | Traditional | PDF ↗ |
| K110037 | PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID | Heraeus Kulzer, LLC | 2011-04-29 | Traditional | PDF ↗ |
| K102874 | NEW STETIC ACRYLICS | New Stetic | 2011-03-28 | Traditional | PDF ↗ |
| K102640 | VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS | Vertex-Dental B.V. | 2011-03-25 | Traditional | PDF ↗ |
| K103391 | IVOBASE HYBRID, IVOBASE HIGH IMPACT | Ivoclar Vivadent, Inc. | 2011-02-17 | Traditional | PDF ↗ |
| K102654 | VERTEX RAPID SIMPLIFIED | Vertex-Dental B.V. | 2010-12-03 | Traditional | PDF ↗ |
| K102207 | FIBER FORCE | Synca Marketing, Inc. | 2010-11-23 | Traditional | PDF ↗ |
| K102347 | GRANDTEC | Voco GmbH | 2010-10-29 | Traditional | PDF ↗ |
| K100653 | JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD | Lang Dental Mfg. Co., Inc. | 2010-10-08 | Traditional | PDF ↗ |
| K081554 | TOKUYAMA TISSUECARE | Tokuyama Dental Corporation | 2009-03-18 | Traditional | PDF ↗ |
| K083479 | BIOCRYL X | Great Lakes Orthodontics, Ltd. | 2009-02-27 | Traditional | PDF ↗ |
| K081537 | CFS FLEXIBLE | Comfort and Flexible Systems | 2009-01-22 | Traditional | PDF ↗ |
| K082180 | PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 | Angelus Industria DE Productos Odontologicos | 2008-12-17 | Traditional | PDF ↗ |
| K082153 | MAJOR.REPAIR | Major Prodotti Dentari S.P.A. | 2008-11-25 | Traditional | PDF ↗ |
| K081981 | LANG DENTAL ACRYLIC PRIMER | Lang Dental Mfg. Co., Inc. | 2008-11-17 | Traditional | PDF ↗ |
| K081884 | MAJOR.BASE 20 | Major Prodotti Dentari S.P.A. | 2008-10-08 | Abbreviated | PDF ↗ |
| K081514 | TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER | Lang Dental Mfg. Co., Inc. | 2008-09-22 | Traditional | PDF ↗ |
| K072851 | POLYSTAR 79 DENTURE BASE RESIN | Cmp Industries, LLC | 2008-02-20 | Traditional | PDF ↗ |
| K073040 | SMH FLEX S | Smh Biomaterial AG | 2007-12-13 | Traditional | PDF ↗ |
| K072479 | FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD | Rapid Injection Systems Corp. | 2007-11-09 | Traditional | PDF ↗ |
| K072580 | JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23 | Lang Dental Mfg. Co., Inc. | 2007-11-05 | Traditional | PDF ↗ |
| K072402 | FLEX-STAR V | Cmp Industries, LLC | 2007-10-19 | Traditional | PDF ↗ |
| K072713 | ION DENTAL RESIN SYSTEM | Dentsply International, Inc. | 2007-10-12 | Traditional | PDF ↗ |
| K071245 | TALON AND REVERE | Talon Acrylics, Inc. | 2007-08-02 | Traditional | PDF ↗ |
| K070698 | COE COMFORT | GC America, Inc. | 2007-03-29 | Special | PDF ↗ |
| K070697 | COE SOFT | GC America, Inc. | 2007-03-29 | Special | PDF ↗ |
| K063626 | DURAFLEX | Cosmetic Dental Materials, Inc. | 2007-02-08 | Traditional | PDF ↗ |
| K063170 | TENDER FIBER | Micerium S.P.A. | 2007-01-12 | Traditional | PDF ↗ |
| K061735 | INFIBRA, MODEL 1200 | Global Dental Products, Inc. | 2006-09-08 | Traditional | PDF ↗ |
| K061580 | ECLIPSE WAX REMOVER | Dentsply International | 2006-07-28 | Traditional | PDF ↗ |
| K061501 | FLEXO DENTAL RESIN MATERIAL | Aci, Inc. | 2006-07-26 | Traditional | PDF ↗ |
| K053060 | TCS UNBREAKABLE | Thermoplastic Comfort Systems, Inc. | 2006-07-20 | Traditional | PDF ↗ |
| K060844 | SILKLINE SOFT RELINING KIT, MODEL 28-100100 | J. Morita USA, Inc. | 2006-06-06 | Traditional | PDF ↗ |
| K053516 | MUCOHARD | Parkell, Inc. | 2006-01-26 | Traditional | PDF ↗ |
| K053328 | BIOSPLINT SPLINTING RIBBON | Satelec | 2006-01-25 | Traditional | PDF ↗ |
| K052780 | DENTAPLAST HOT, MODEL 16-XXX | Bredent-Products For the Dental Technician Laborat | 2005-12-21 | Traditional | PDF ↗ |
| K052073 | FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000 | Schutz-Dental GmbH | 2005-10-26 | Traditional | PDF ↗ |
| K051358 | NATURE-CRYL HI PLUS | GC America, Inc. | 2005-07-07 | Traditional | PDF ↗ |
| K043504 | PALAIMPACT | Heraeus Kulzer, Inc. | 2005-01-28 | Traditional | PDF ↗ |
| K043295 | VERSYO.DIRECT | Heraeus Kulzer, Inc. | 2005-01-05 | Traditional | PDF ↗ |
| K042931 | TUF LINK SILICONE RELINER | Dentatus USA , Ltd. | 2004-12-08 | Traditional | PDF ↗ |
| K040881 | METACRYL | Great Lakes Orthodontics, Ltd. | 2004-05-25 | Traditional | PDF ↗ |
| K034024 | TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS | Bisco, Inc. | 2004-03-19 | Traditional | PDF ↗ |
| K033632 | VARIFLEX | Great Lakes Orthodontics, Ltd. | 2004-01-21 | Traditional | PDF ↗ |
| K033472 | TESCERA U-BAR AND BARRELS | Bisco, Inc. | 2004-01-15 | Traditional | PDF ↗ |
| K033629 | VERSYO.BOND | Heraeus Kulzer, Inc. | 2003-12-22 | Traditional | PDF ↗ |
| K033020 | IMPAK ACRYLIC REPAIR RESIN LIQUID | Cmp Industries, LLC | 2003-12-19 | Traditional | PDF ↗ |
| K032892 | MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM | Dentsply Intl. | 2003-09-26 | Special | PDF ↗ |
| K032773 | DIAMOND D HIGH IMPACT DENTURE ACRYLIC | Mycone Dental Supply Co., Inc. | 2003-09-23 | Special | PDF ↗ |
| K031070 | CARBON FIBER BRIDGE, MODEL 28757 | Nobel Biocare AB | 2003-07-03 | Traditional | PDF ↗ |
| K030916 | UFI GEL HARD C | Voco GmbH | 2003-06-19 | Traditional | PDF ↗ |
| K030663 | TOKUYAMA SOFRELINER TOUGH | Tokuyama Dental Corporation | 2003-05-29 | Traditional | PDF ↗ |
| K030072 | EVERSTICK PERIO | Stick Tech , Ltd. | 2003-04-10 | Traditional | PDF ↗ |
| K022641 | TOKUYAMA REBASE II | Tokuyama America, Inc. | 2002-10-02 | Traditional | PDF ↗ |
| K021437 | SECURE SOFT | Imtec Corp. | 2002-07-19 | Traditional | PDF ↗ |
| K021586 | SECURE RELINE/PICKUP MATERIAL | Imtec Corp. | 2002-06-14 | Traditional | PDF ↗ |
| K021121 | AROMACRYL | Aromacryl, LLC | 2002-05-28 | Traditional | PDF ↗ |
| K021126 | EVERSTICK ORTHO | Stick Tech , Ltd. | 2002-05-13 | Traditional | PDF ↗ |
| K013881 | RIBBOND - TRIAXIAL | Ribbond, Inc. | 2002-01-25 | Traditional | PDF ↗ |
| K012882 | BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060 | Thermoelastic Technologies, Inc. | 2001-11-14 | Traditional | PDF ↗ |
| K011799 | EVERSTICKNET | Stick Tech , Ltd. | 2001-11-05 | Traditional | PDF ↗ |
| K011788 | EVERSTICK | Stick Tech , Ltd. | 2001-11-05 | Traditional | PDF ↗ |
| K011820 | DENTORIUM CONVERTIBLE ACRYLIC | Nats Corp. | 2001-09-05 | Traditional | PDF ↗ |
| K011762 | HI-WAVE; POUR-PLUS | Denplus, Inc. | 2001-08-23 | Traditional | PDF ↗ |
| K011560 | TRUBYTE DENTURE BASE RESIN SYSTEM | Dentsply Intl. | 2001-07-12 | Traditional | PDF ↗ |
| K011277 | HARD RELINER | S & C Polymer GmbH | 2001-06-26 | Traditional | PDF ↗ |
| K010800 | VERSYO.COM | Heraeus Kulzer, Inc. | 2001-05-31 | Traditional | PDF ↗ |
| K003334 | STICK NET | Stick Tech , Ltd. | 2001-01-08 | Traditional | PDF ↗ |
| K003333 | STICK | Stick Tech , Ltd. | 2001-01-04 | Traditional | PDF ↗ |
| K002048 | JBC OPAQUE AND GLITTER | J.B.C and Co. | 2000-08-30 | Traditional | PDF ↗ |
| K001640 | BIOSOFT RESIN | Biosoft International Corp. | 2000-06-23 | Traditional | PDF ↗ |
| K001463 | SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 | Davis Schottlander & Davis, Ltd. | 2000-06-16 | Traditional | PDF ↗ |
| K992176 | EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL | St. George Technology, Inc. | 2000-02-10 | Traditional | PDF ↗ |
| K993827 | UFI GEL HARD | Voco GmbH | 2000-01-20 | Traditional | PDF ↗ |
| K993717 | ENIGMA HI-BASE DENTURE BASE MATERIAL | Davis Schottlander & Davis, Ltd. | 1999-12-22 | Traditional | PDF ↗ |
| K991687 | MODIFICATION TO LINER II: SOFT RELINE LIQUID | Bosworth Co. | 1999-10-07 | Traditional | PDF ↗ |
| K992956 | LUCITONE FRS FLEXIBEL DENTAL RESIN | Dentsply Intl. | 1999-10-06 | Traditional | PDF ↗ |
| K991577 | NIC TONE ACRYLIC RESINS | Manufacturera Dental Continental | 1999-09-22 | Traditional | PDF ↗ |
| K992609 | HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 | Kay See Dental Mfg. Co. | 1999-09-22 | Traditional | PDF ↗ |
| K991996 | IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR | Denplus, Inc. | 1999-09-08 | Traditional | PDF ↗ |
| K991774 | ACRON MC MODIFICATION | GC America, Inc. | 1999-07-09 | Traditional | PDF ↗ |
| K990736 | GC RELINE SOFT/EXTRA SOFT | GC America, Inc. | 1999-05-28 | Traditional | PDF ↗ |
| K990763 | VITRON M | Espe Dental AG | 1999-05-25 | Traditional | PDF ↗ |
| K991220 | VITRON H | Espe Dental AG | 1999-05-20 | Traditional | PDF ↗ |
| K990699 | ORTHO-GLOW GLITTER | Harry J. Bosworth Co. | 1999-05-17 | Traditional | PDF ↗ |
| K983461 | UNI-FLEX RESIN | Trans-Atlantic Dental | 1999-04-13 | Traditional | PDF ↗ |
| K990056 | JELDENT MULTICRYL | J.F. Jelenko & Co., Inc. | 1999-03-25 | Traditional | PDF ↗ |
| K990448 | THE.R.MO.FREE | Dentamax, Inc. | 1999-03-23 | Traditional | PDF ↗ |
| K984365 | GC UNIFAST TRAD | GC America, Inc. | 1999-02-25 | Traditional | PDF ↗ |
Product code EBI · Class II · Dental. Data: openFDA.