Resin, Denture, Relining, Repairing, Rebasing
Regulation 872.3760
10510(k)s in 12 months (335 all time)
0recalls in 12 months (16 all time)
10recalls that name a 510(k)
Top companies in EBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Dentsply Intl. | 16 | 0 |
| Heraeus Kulzer, Inc. | 13 | 0 |
| GC America, Inc. | 12 | 0 |
| Cmp Industries, LLC | 5 | 6 |
| Harry J. Bosworth Co. | 8 | 0 |
| Lang Dental Mfg. Co., Inc. | 7 | 1 |
| Voco GmbH | 8 | 0 |
| Vertex-Dental B.V. | 7 | 0 |
| Dentsply Sirona | 6 | 0 |
| Stick Tech , Ltd. | 6 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 1, 2013 | K123220 | VERTEX THERMOSENS RIGID Vertex-Dental B.V. | EBI |
| Jan 10, 2013 | K123396 | I.FLEX BY TCS Thermoplastic Comfort Systems, Inc. | EBI |
| Oct 15, 2012 | K122348 | QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW Recherches Techniques Dentaires (R.T.D.), FR | EBI |
| Apr 10, 2012 | K113608 | DEFLEX Nuxen S.R.L., AR | EBI |
| Mar 16, 2012 | K113788 | DEFLEX ACRILATO Nuxen S.R.L., AR | EBI |
| Nov 18, 2011 | K111709 | FOUNDATION DENTAL RESIN Unix-Japan Co., Ltd. | EBI |
| Nov 4, 2011 | K112397 | ORTHO-JET CRYSTAL Lang Dental Mfg. Co., Inc. | EBI |
| Oct 28, 2011 | K112445 | SOFRELINER TOUGH S Tokuyama Dental Corporation | EBI |
| Sep 29, 2011 | K111832 | PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID Heraeus Kulzer, LLC | EBI |
| Sep 12, 2011 | K111178 | JUELL SOFT CURE Juell Dental | EBI |
| Sep 12, 2011 | K111177 | JUELL HARD CURE Juell Dental | EBI |
| May 4, 2011 | K110440 | QUICK UP Voco GmbH, DE | EBI |
| Apr 29, 2011 | K110037 | PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID Heraeus Kulzer, LLC | EBI |
| Mar 28, 2011 | K102874 | NEW STETIC ACRYLICS New Stetic | EBI |
| Mar 25, 2011 | K102640 | VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS Vertex-Dental B.V. | EBI |
| Feb 17, 2011 | K103391 | IVOBASE HYBRID, IVOBASE HIGH IMPACT Ivoclar Vivadent, Inc. | EBI |
| Dec 3, 2010 | K102654 | VERTEX RAPID SIMPLIFIED Vertex-Dental B.V. | EBI |
| Nov 23, 2010 | K102207 | FIBER FORCE Synca Marketing, Inc. | EBI |
| Oct 29, 2010 | K102347 | GRANDTEC Voco GmbH, DE | EBI |
| Oct 8, 2010 | 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. | EBI |
| Mar 18, 2009 | K081554 | TOKUYAMA TISSUECARE Tokuyama Dental Corporation | EBI |
| Feb 27, 2009 | K083479 | BIOCRYL X Great Lakes Orthodontics, Ltd. | EBI |
| Jan 22, 2009 | K081537 | CFS FLEXIBLE Comfort and Flexible Systems | EBI |
| Dec 17, 2008 | K082180 | PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 Angelus Industria DE Productos Odontologicos | EBI |
| Nov 25, 2008 | K082153 | MAJOR.REPAIR Major Prodotti Dentari S.P.A., IT | EBI |
| Nov 17, 2008 | K081981 | LANG DENTAL ACRYLIC PRIMER Lang Dental Mfg. Co., Inc. | EBI |
| Oct 8, 2008 | K081884 | MAJOR.BASE 20 Major Prodotti Dentari S.P.A., IT | EBI |
| Sep 22, 2008 | K081514 | TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER Lang Dental Mfg. Co., Inc. | EBI |
| Feb 20, 2008 | K072851 | POLYSTAR 79 DENTURE BASE RESIN Cmp Industries, LLC | EBI |
| Dec 13, 2007 | K073040 | SMH FLEX S Smh Biomaterial AG | EBI |
| Nov 9, 2007 | K072479 | FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD Rapid Injection Systems Corp. | EBI |
| Nov 5, 2007 | 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. | EBI |
| Oct 19, 2007 | K072402 | FLEX-STAR V Cmp Industries, LLC | EBI |
| Oct 12, 2007 | K072713 | ION DENTAL RESIN SYSTEM Dentsply International, Inc. | EBI |
| Aug 2, 2007 | K071245 | TALON AND REVERE Talon Acrylics, Inc. | EBI |
| Mar 29, 2007 | K070698 | COE COMFORT GC America, Inc. | EBI |
| Mar 29, 2007 | K070697 | COE SOFT GC America, Inc. | EBI |
| Feb 8, 2007 | K063626 | DURAFLEX Cosmetic Dental Materials, Inc. | EBI |
| Jan 12, 2007 | K063170 | TENDER FIBER Micerium S.P.A., IT | EBI |
| Sep 8, 2006 | K061735 | INFIBRA, MODEL 1200 Global Dental Products, Inc. | EBI |
| Jul 28, 2006 | K061580 | ECLIPSE WAX REMOVER Dentsply International | EBI |
| Jul 26, 2006 | K061501 | FLEXO DENTAL RESIN MATERIAL Aci, Inc. | EBI |
| Jul 20, 2006 | K053060 | TCS UNBREAKABLE Thermoplastic Comfort Systems, Inc. | EBI |
| Jun 6, 2006 | K060844 | SILKLINE SOFT RELINING KIT, MODEL 28-100100 J. Morita USA, Inc. | EBI |
| Jan 26, 2006 | K053516 | MUCOHARD Parkell, Inc. | EBI |
| Jan 25, 2006 | K053328 | BIOSPLINT SPLINTING RIBBON Satelec | EBI |
| Dec 21, 2005 | K052780 | DENTAPLAST HOT, MODEL 16-XXX Bredent-Products For the Dental Technician Laborat, DE | EBI |
| Oct 26, 2005 | K052073 | FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000 Schutz-Dental GmbH, DE | EBI |
| Jul 7, 2005 | K051358 | NATURE-CRYL HI PLUS GC America, Inc. | EBI |
| Jan 28, 2005 | K043504 | PALAIMPACT Heraeus Kulzer, Inc. | EBI |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.