Sealant, Pit And Fissure, And Conditioner
Regulation 872.3765
1510(k)s in 12 months (131 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in EBC
| Company | 510(k)s | Recalls |
|---|---|---|
| Dentsply Intl. | 11 | 0 |
| Pulpdent Corp. | 10 | 0 |
| Ultradent Products, Inc. | 7 | 1 |
| Voco GmbH | 5 | 0 |
| Confi-Dental Products Co. | 4 | 0 |
| 3M Company | 3 | 0 |
| Bisco, Inc. | 3 | 0 |
| Foremost Dental Mfg., Inc. | 3 | 0 |
| Harry J. Bosworth Co. | 3 | 0 |
| Johnson & Johnson Professionals, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 1, 2026 | K260819 | Any-Com Seal Mediclus Co., Ltd., KR | EBC |
| Aug 8, 2025 | K243254 | Parkell Pit and Fissure Sealant Parkell, Inc. | EBC |
| Aug 18, 2023 | K232498 | UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio Ultradent Product, Inc. | EBC |
| Jul 25, 2023 | K230455 | Enamel Coating Resin Rizhao Huge Biomaterials Company, Ltd., CN | EBC |
| Nov 8, 2019 | K190998 | BA Pit & Fissure Sealant Apex Dental Materials, Inc. | EBC |
| Jul 29, 2019 | K190339 | Helioseal F Plus Ivoclar Vivadent, AG, LI | EBC |
| Jan 5, 2018 | K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCP Pulpdent Corporation | EBC |
| Sep 8, 2017 | K171330 | Nanova Sealant Nanova Biomaterials, Inc. | EBC |
| May 23, 2017 | K162598 | HAPI Seal Bisco, Inc. | EBC |
| Oct 18, 2016 | K161580 | Premier Sealant Premier Dental Company Products | EBC |
| Mar 9, 2015 | K141717 | PACSEAL PIT & FISSURE SEALANT Pac-Dent International, Inc. | EBC |
| Feb 11, 2014 | K130485 | CONTROL SEAL Voco GmbH, DE | EBC |
| Jun 11, 2013 | K122521 | PREVENT SEAL Itena Clinical, CA | EBC |
| Mar 21, 2012 | K113818 | EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL Pulpdent Corporation | EBC |
| Sep 23, 2011 | K112517 | ULTRASEAL XT HYDRO Ultradent Products, Inc. | EBC |
| Sep 16, 2011 | K111782 | BEAUTISEALANT Shofu Dental Corporation | EBC |
| Mar 31, 2011 | K110058 | BPA-FREE PIT AND FISSURE SEALANT Novocol Inc. Dba Septodont and Confi-Dental Produc | EBC |
| Dec 3, 2010 | K102252 | DMP PIT & FISSURE SEALANT Dmp, Ltd., GR | EBC |
| Oct 26, 2010 | K103121 | ECO-S Vericom Co., Ltd., KR | EBC |
| Sep 17, 2010 | K101245 | ULTRASEAL ID Ultradent Products, Inc. | EBC |
| Mar 26, 2010 | K100062 | INFILTRATION KIT Dmg USA, Inc. | EBC |
| Feb 4, 2010 | K093059 | SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT Classone Orthodontics, Inc. | EBC |
| Sep 3, 2009 | K091632 | SPK SEALANT 3M Company | EBC |
| Jan 22, 2009 | K083473 | CLEAR BRAVO Denali R&D Corporation | EBC |
| Sep 18, 2008 | K081493 | INFILTRATION KIT Dmg USA, Inc. | EBC |
| Jun 5, 2007 | K071158 | AURALAY PIT & FISSURE SEALANT Denali Corporation | EBC |
| Nov 6, 2006 | K062886 | ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 CAO Group, Inc. | EBC |
| Oct 4, 2006 | K061997 | PREMIER SELF-ETCHING ENAMEL SEALANT Premier Dental Products Co. | EBC |
| Oct 2, 2006 | K062344 | GRANDIO SEAL Voco GmbH, DE | EBC |
| Jul 21, 2006 | K061823 | ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE Voco GmbH, DE | EBC |
| Feb 8, 2006 | K052281 | EMBRACE WETBOND CLEAR SEALANT Pulpdent Corporation | EBC |
| Dec 20, 2005 | K053089 | ASCENT PIT & FISSURE SEALANT CAO Group, Inc. | EBC |
| Jul 28, 2005 | K051224 | BOSWORTH SEAL Harry J. Bosworth Co. | EBC |
| Jun 10, 2005 | K050871 | RIVA PROTECT Southern Dental Industries, Inc., AU | EBC |
| May 11, 2005 | K050959 | DELTON ILLUMINATING PIT AND FISSURE SEALING Dentsply International | EBC |
| Dec 1, 2004 | K042823 | COSMEDENT PIT & FISSURE SEALANT Cosmedent, Inc. | EBC |
| Feb 5, 2004 | K033751 | AEGIS PIT & FISSURE SEALANT WITH ACP Harry J. Bosworth Co. | EBC |
| Sep 4, 2003 | K031811 | PIT & FISSURE SEALANT WITH FLUORIDE Harry J. Bosworth Co. | EBC |
| Jul 29, 2002 | K021842 | ADMIRA SEAL Voco GmbH | EBC |
| Jul 19, 2002 | K021844 | ADMIRA PROTECT Voco GmbH | EBC |
| Apr 12, 2002 | K020287 | DENTITION INTEGRATING MATERIAL Pulpdent Corporation | EBC |
| Nov 1, 2001 | K012761 | PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT Prime Dental Manufacturing, Inc. | EBC |
| Oct 16, 2001 | K012542 | REVOTEK LC GC America, Inc. | EBC |
| Sep 14, 2001 | K012742 | TEETHMATE F-1 Kuraray Medical, Inc. | EBC |
| Sep 6, 2001 | K011908 | OPTIBOND SOLO PLUS 3 Kerr Dental Materials Center | EBC |
| Aug 16, 2001 | K011491 | HELIOSEAL CLEAR CHROMA Ivoclar North America, Inc. | EBC |
| Aug 7, 2001 | K011822 | PIT AND FISSURE CHEMICAL CURING SEALANT Rite-Dent Manufacturing Corp. | EBC |
| Feb 16, 2000 | K993846 | ULTRASEAL XT PLUS Ultradent Products, Inc. | EBC |
| Oct 22, 1999 | K992519 | NRC NON-RINSE CONDITIONER Dentsply Intl. | EBC |
| Oct 8, 1999 | K992326 | 3M CLINPRO SEALANT 3M Company | EBC |
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