Varnish, Cavity
Regulation 872.3260
6510(k)s in 12 months (139 all time)
0recalls in 12 months (9 all time)
6recalls that name a 510(k)
Top companies in LBH
| Company | 510(k)s | Recalls |
|---|---|---|
| Pulpdent Corp. | 10 | 0 |
| Ultradent Products, Inc. | 9 | 1 |
| Scientific Pharmaceuticals | 9 | 0 |
| Dentsply Intl. | 6 | 0 |
| Novamin Technology, Inc. | 6 | 0 |
| Centrix, Inc. | 5 | 0 |
| Ivoclar Vivadent, AG | 4 | 0 |
| CAO Group, Inc. | 3 | 0 |
| Dental Dimensions Supply Co. | 3 | 0 |
| Voco GmbH | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 2010 | K093620 | PULPDENT FLUORIDE VARNISH Pulpdent Corporation | LBH |
| Mar 10, 2010 | K092141 | VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH 3M Espe Dental Products | LBH |
| Mar 5, 2010 | K093575 | GLUMA DESENSITIZER POWER GEL Heraeus Kulzer, LLC | LBH |
| Apr 15, 2009 | K090519 | VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247 3M Company | LBH |
| Mar 19, 2009 | K082594 | REMESENSE Remedent NV | LBH |
| Mar 16, 2009 | K090597 | FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH Pascal Co., Inc. | LBH |
| Jan 12, 2009 | K083036 | VOCO PROFLUORID L Voco GmbH, DE | LBH |
| Oct 29, 2008 | K082198 | DURASHIELD PLUS Dentsply Intl., Inc. | LBH |
| Oct 2, 2008 | K082071 | ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT Adpharma, Inc. | LBH |
| Jul 24, 2008 | K080814 | VOCO PROFLUORID VARNISH Voco GmbH, DE | LBH |
| Mar 27, 2008 | K080228 | ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH Novamin Technology, Inc. | LBH |
| Feb 29, 2008 | K073061 | THE PROXIVENT KIT Coll Partners , Ltd., IL | LBH |
| Feb 8, 2008 | K080249 | FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 Ultradent Products, Inc. | LBH |
| Dec 19, 2007 | K073117 | DENTIN DESENSITIZER AGENT Dentsply Intl., Inc. | LBH |
| Oct 3, 2007 | K072342 | SULTAN TOOTH ROOT DESENSITIZER Dentsply International, Inc. | LBH |
| Sep 21, 2007 | K072338 | CERVITEC PLUS Ivoclar Vivadent, Inc. | LBH |
| Jun 12, 2007 | K061438 | ULTRAEZ DESENSITIZING GEL Ultradent Products, Inc. | LBH |
| May 25, 2007 | K070070 | ASCENT DENTAL CLEANSER CAO Group, Inc. | LBH |
| May 18, 2007 | K071267 | PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN Novamin Technology, Inc. | LBH |
| May 4, 2007 | K070289 | ACQUASEAL BENZ Acquamed Technologies, Inc. | LBH |
| Jan 10, 2007 | K062176 | RELIEF ACP ORAL CARE GEL Discus Dental, Inc. | LBH |
| Nov 21, 2006 | K062683 | ENAMEL PRO VARNISH Premier Dental Products Co. | LBH |
| Oct 18, 2006 | K061359 | DENSHIELD TREATMENT FOR SENSITIVE TEETH Novamin Technology, Inc. | LBH |
| Dec 16, 2005 | K052263 | MULTIPLE (TOOTH DESENSITIZER) Cosmedent, Inc. | LBH |
| Sep 19, 2005 | K051750 | FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 Ultradent Products, Inc. | LBH |
| Jun 7, 2005 | K050486 | PROTECT TOOTH DESENSITIZER Sunstar Butler | LBH |
| Sep 2, 2004 | K040858 | ORALIEF THERAPY FOR SENSITIVE TEETH Novamin Technology, Inc. | LBH |
| Mar 10, 2004 | K040473 | ORAVIVE TOOTH REVITALIZING PASTE Novamin Technology, Inc. | LBH |
| Feb 4, 2004 | K040098 | VARNISHAMERICA Medical Products Laboratories, Inc. | LBH |
| Oct 28, 2003 | K033295 | BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN Novamin Technology, Inc. | LBH |
| Oct 17, 2003 | K030922 | VIVASENS Ivoclar Vivadent, Inc. | LBH |
| Sep 15, 2003 | K031932 | FLUORIDE VARNISH Dentsply Intl. | LBH |
| May 2, 2003 | K030488 | FLUORILAQ Pascal Co., Inc. | LBH |
| Nov 25, 2002 | K023671 | AQUEOUS ACRYLIC DISPERSION 28% W/W Chx Technologies, Inc., CA | LBH |
| Sep 26, 2002 | K021131 | CHLORAPREP Centrix, Inc. | LBH |
| Aug 19, 2002 | K021805 | SEAL & PROTECT PROTECTIVE SEALANT Dentsply Intl. | LBH |
| Dec 12, 2001 | K013411 | PULPDENT CAVITY PREPARATION IV Pulpdent Corp. | LBH |
| Jun 25, 2001 | K010957 | QUELL DESENSITIZER Jeneric/Pentron, Inc. | LBH |
| Apr 20, 2001 | K010255 | CAVITY VARNISH Rite-Dent Manufacturing Corp. | LBH |
| Feb 1, 2001 | K003482 | PROCLUDE-SENSITIVE Ortek Therapeutics, Inc. | LBH |
| Oct 20, 2000 | K002581 | DURAGARD SODIUM FLUORIDE VARNISH Sultan Dental Products, Ltd. | LBH |
| Mar 2, 2000 | K994180 | PULPDENT CAVITY PREPARATION III Pulpdent Corp. | LBH |
| Feb 29, 2000 | K994181 | PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE Pulpdent Corp. | LBH |
| Feb 23, 2000 | K994182 | PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE Pulpdent Corp. | LBH |
| Nov 17, 1999 | K992822 | SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE Dentsply Intl. | LBH |
| Nov 17, 1999 | K990779 | HEMASEAL & CIDE Advantage Dental Products, Inc. | LBH |
| Oct 22, 1999 | K992629 | D/SENSE II (GREEN-OR) DENTIN DESENSITIZER Centrix, Inc. | LBH |
| Feb 12, 1999 | K982915 | SCI-PHARM DFV VARNISH Scientific Pharmaceuticals, Inc. | LBH |
| Dec 17, 1998 | K983305 | SCI-PHARM DESENSITIZING VARNISH Scientific Pharmaceuticals, Inc. | LBH |
| Dec 7, 1998 | K981972 | GREEN-OR DENTIN DESENSITIZER Centrix, Inc. | LBH |
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