Crown And Bridge, Temporary, Resin
Regulation 872.3770
2510(k)s in 12 months (189 all time)
0recalls in 12 months (4 all time)
2recalls that name a 510(k)
Top companies in EBG
| Company | 510(k)s | Recalls |
|---|---|---|
| GC America, Inc. | 6 | 0 |
| Ivoclar Vivadent, Inc. | 6 | 0 |
| Sybron Dental Specialties, Inc. | 6 | 0 |
| Dmg USA, Inc. | 5 | 0 |
| Voco GmbH | 5 | 0 |
| 3M Company | 4 | 0 |
| Lang Dental Mfg. Co., Inc. | 2 | 2 |
| Espe GmbH (Us) | 3 | 0 |
| Ivoclar North America, Inc. | 3 | 0 |
| Kerr Dental Materials Center | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 14, 2015 | K151144 | SuPro 100 3M Deutschland GmbH, DE | EBG |
| Aug 14, 2015 | K150432 | IDODENTINE DISC, IDODENTINE BLOCK Union Dental S.A., ES | EBG |
| Apr 24, 2015 | K142371 | Luminesse PMMA Talladium, Inc. | EBG |
| Feb 12, 2015 | K133268 | TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS Schutz-Dental GmbH, DE | EBG |
| Feb 9, 2015 | K141421 | PMMA BLOCK Rizhao Huge Dental Industry Co., Ltd., CN | EBG |
| Sep 5, 2014 | K141562 | MSN-006 GC America, Inc. | EBG |
| Jul 31, 2014 | K140894 | ARGEN PMMA The Argen Corporation | EBG |
| May 21, 2014 | K132937 | HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) Harvest Dental Products, LLC | EBG |
| Dec 18, 2013 | K131664 | COPRA TEMP PMMA-DISK White Peaks Dental Systems GmbH & Co. KG | EBG |
| Feb 21, 2013 | K123638 | PEKKTON IVORY Cendres & Metaux SA, CH | EBG |
| Dec 27, 2012 | K122039 | KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B Kettenbach GmbH & Co. KG, DE | EBG |
| Oct 9, 2012 | K122025 | BRIGHTGLASS BRIGHTGLASS M Ktk Medical Supplies GmbH, DE | EBG |
| Aug 28, 2012 | K112967 | PMMA CAD/CAM DISC Polident D.O.O., Dental Products Industry, SI | EBG |
| Jun 8, 2012 | K120784 | TUFF-TEMP 2.0 Pulpdent Corporation | EBG |
| Jun 1, 2012 | K120779 | STRUCTUR 3 Voco GmbH, DE | EBG |
| Nov 8, 2011 | K112186 | FIBER DISK AND BLOCK Bioloren S.R.L., IT | EBG |
| Sep 7, 2011 | K111666 | EVADYNE TEMPORARY CROWN AND BRIDGE RESIN Neodental Chemical Products Co., Ltd. | EBG |
| Jun 17, 2011 | K102917 | FIXTEMP C&B Exacta Dental Direct, Inc. | EBG |
| Jun 14, 2011 | K110747 | TEMPFLEX Kerr Corporation | EBG |
| May 25, 2011 | K103514 | PRO-V COAT Bisco, Inc. | EBG |
| May 17, 2011 | K110484 | SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL Novocol, Inc. | EBG |
| Feb 18, 2011 | K102776 | EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM Deltamed GmbH, DE | EBG |
| Feb 14, 2011 | K103379 | TELIO CS INLAY & TELIO CS ONLAY Ivoclar Vivadent, Inc. | EBG |
| Feb 7, 2011 | K103474 | ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) Micerium S.P.A., IT | EBG |
| Feb 4, 2011 | K102753 | TURBO TEMP 3 Danville Materials, Inc. | EBG |
| Dec 16, 2010 | K102341 | VIPI BLOCK Vipi Industria,Comercio,Exportacao E Importacao DE | EBG |
| Sep 28, 2010 | K101710 | LUXATEMP ULTRA /STAR Dmg USA, Inc. | EBG |
| Sep 27, 2010 | K101814 | DIRECT CROWN NATURAL 1 Candulor USA, Inc. | EBG |
| Mar 10, 2010 | K093708 | TELIO CAD Ivoclar Vivadent, Inc. | EBG |
| Mar 5, 2010 | K093380 | MIZZY EXPRESS Mycone Dental Supply Co., Inc. | EBG |
| Jul 23, 2009 | K091894 | TEMPORARY C&B COMPOSITE Voco GmbH, DE | EBG |
| Jun 5, 2009 | K083195 | MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN Lang Dental Mfg. Co., Inc. | EBG |
| Dec 9, 2008 | K082700 | TEMPORARY COLD.V AND SELF-CURE DENTINE Major Prodotti Dentari S.P.A., IT | EBG |
| Sep 17, 2008 | K081810 | PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL Pulpdent Corporation | EBG |
| Sep 17, 2008 | K081705 | LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN Lang Dental Mfg. Co., Inc. | EBG |
| May 2, 2008 | K080556 | ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES Merz Dental GmbH | EBG |
| Apr 18, 2008 | K080311 | MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM Dentsply Interntional | EBG |
| Apr 11, 2008 | K073106 | UNIFAST III GC America, Inc. | EBG |
| Apr 8, 2008 | K080182 | ZENO PMMA DISC Wieland Dental + Technik GmbH & Co. KG, DE | EBG |
| Feb 14, 2008 | K073263 | PRO-V Bisco, Inc. | EBG |
| Jan 9, 2008 | K073296 | TEMPXN28 3M Espe AG Dental Products, DE | EBG |
| Aug 21, 2007 | K071548 | WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED Merz Dental GmbH | EBG |
| Jun 1, 2007 | K070991 | VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310 Vita | EBG |
| Feb 8, 2007 | K063624 | KAVO EVEREST C-TEMP Kavo America | EBG |
| Sep 13, 2006 | K061809 | ARTEGRAL IMCROWN Merz Dental GmbH | EBG |
| Jul 21, 2006 | K061530 | MD-TEMP Meta Biomed Co., Ltd., KR | EBG |
| May 23, 2006 | K061264 | TEMPFX ESTHETIC PROVISIONAL SYSTEM Dentsply International, Inc. | EBG |
| May 16, 2006 | K060881 | TEMPORARY CROWN & BRIDGE RESIN Cosmedent, Inc. | EBG |
| Mar 7, 2006 | K052800 | PROVISIONAL INLAY/ONLAY KIT Dmg USA, Inc. | EBG |
| Feb 17, 2006 | K060293 | TEMPORARY CROWN AND BRIDGE MATERIAL Dentsply International, Inc. | EBG |
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