FDA Product Code
FDA Product Code EBC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3765
510(k) Clearances — 131 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260819 | Any-Com Seal | Mediclus Co., Ltd. | 2026-05-01 | Traditional | PDF ↗ |
| K243254 | Parkell Pit and Fissure Sealant | Parkell, Inc. | 2025-08-08 | Abbreviated | PDF ↗ |
| K232498 | UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio | Ultradent Product, Inc. | 2023-08-18 | Traditional | PDF ↗ |
| K230455 | Enamel Coating Resin | Rizhao Huge Biomaterials Company, Ltd. | 2023-07-25 | Traditional | PDF ↗ |
| K190998 | BA Pit & Fissure Sealant | Apex Dental Materials, Inc. | 2019-11-08 | Abbreviated | PDF ↗ |
| K190339 | Helioseal F Plus | Ivoclar Vivadent, AG | 2019-07-29 | Abbreviated | PDF ↗ |
| K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCP | Pulpdent Corporation | 2018-01-05 | Traditional | PDF ↗ |
| K171330 | Nanova Sealant | Nanova Biomaterials, Inc. | 2017-09-08 | Traditional | PDF ↗ |
| K162598 | HAPI Seal | Bisco, Inc. | 2017-05-23 | Traditional | PDF ↗ |
| K161580 | Premier Sealant | Premier Dental Company Products | 2016-10-18 | Traditional | PDF ↗ |
| K141717 | PACSEAL PIT & FISSURE SEALANT | Pac-Dent International, Inc. | 2015-03-09 | Traditional | PDF ↗ |
| K130485 | CONTROL SEAL | Voco GmbH | 2014-02-11 | Traditional | PDF ↗ |
| K122521 | PREVENT SEAL | Itena Clinical | 2013-06-11 | Traditional | PDF ↗ |
| K113818 | EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL | Pulpdent Corporation | 2012-03-21 | Traditional | PDF ↗ |
| K112517 | ULTRASEAL XT HYDRO | Ultradent Products, Inc. | 2011-09-23 | Special | PDF ↗ |
| K111782 | BEAUTISEALANT | Shofu Dental Corporation | 2011-09-16 | Traditional | PDF ↗ |
| K110058 | BPA-FREE PIT AND FISSURE SEALANT | Novocol Inc. Dba Septodont and Confi-Dental Produc | 2011-03-31 | Abbreviated | PDF ↗ |
| K102252 | DMP PIT & FISSURE SEALANT | Dmp, Ltd. | 2010-12-03 | Traditional | PDF ↗ |
| K103121 | ECO-S | Vericom Co., Ltd. | 2010-10-26 | Traditional | PDF ↗ |
| K101245 | ULTRASEAL ID | Ultradent Products, Inc. | 2010-09-17 | Special | PDF ↗ |
| K100062 | INFILTRATION KIT | Dmg USA, Inc. | 2010-03-26 | Abbreviated | PDF ↗ |
| K093059 | SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT | Classone Orthodontics, Inc. | 2010-02-04 | Traditional | PDF ↗ |
| K091632 | SPK SEALANT | 3M Company | 2009-09-03 | Traditional | PDF ↗ |
| K083473 | CLEAR BRAVO | Denali R&D Corporation | 2009-01-22 | Traditional | PDF ↗ |
| K081493 | INFILTRATION KIT | Dmg USA, Inc. | 2008-09-18 | Abbreviated | PDF ↗ |
| K071158 | AURALAY PIT & FISSURE SEALANT | Denali Corporation | 2007-06-05 | Traditional | PDF ↗ |
| K062886 | ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 | CAO Group, Inc. | 2006-11-06 | Special | PDF ↗ |
| K061997 | PREMIER SELF-ETCHING ENAMEL SEALANT | Premier Dental Products Co. | 2006-10-04 | Traditional | PDF ↗ |
| K062344 | GRANDIO SEAL | Voco GmbH | 2006-10-02 | Abbreviated | PDF ↗ |
| K061823 | ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE | Voco GmbH | 2006-07-21 | Special | PDF ↗ |
| K052281 | EMBRACE WETBOND CLEAR SEALANT | Pulpdent Corporation | 2006-02-08 | Traditional | PDF ↗ |
| K053089 | ASCENT PIT & FISSURE SEALANT | CAO Group, Inc. | 2005-12-20 | Traditional | PDF ↗ |
| K051224 | BOSWORTH SEAL | Harry J. Bosworth Co. | 2005-07-28 | Traditional | PDF ↗ |
| K050871 | RIVA PROTECT | Southern Dental Industries, Inc. | 2005-06-10 | Traditional | PDF ↗ |
| K050959 | DELTON ILLUMINATING PIT AND FISSURE SEALING | Dentsply International | 2005-05-11 | Special | PDF ↗ |
| K042823 | COSMEDENT PIT & FISSURE SEALANT | Cosmedent, Inc. | 2004-12-01 | Traditional | PDF ↗ |
| K033751 | AEGIS PIT & FISSURE SEALANT WITH ACP | Harry J. Bosworth Co. | 2004-02-05 | Traditional | PDF ↗ |
| K031811 | PIT & FISSURE SEALANT WITH FLUORIDE | Harry J. Bosworth Co. | 2003-09-04 | Traditional | PDF ↗ |
| K021842 | ADMIRA SEAL | Voco GmbH | 2002-07-29 | Traditional | PDF ↗ |
| K021844 | ADMIRA PROTECT | Voco GmbH | 2002-07-19 | Traditional | PDF ↗ |
| K020287 | DENTITION INTEGRATING MATERIAL | Pulpdent Corporation | 2002-04-12 | Traditional | PDF ↗ |
| K012761 | PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT | Prime Dental Manufacturing, Inc. | 2001-11-01 | Traditional | PDF ↗ |
| K012542 | REVOTEK LC | GC America, Inc. | 2001-10-16 | Traditional | PDF ↗ |
| K012742 | TEETHMATE F-1 | Kuraray Medical, Inc. | 2001-09-14 | Traditional | PDF ↗ |
| K011908 | OPTIBOND SOLO PLUS 3 | Kerr Dental Materials Center | 2001-09-06 | Traditional | PDF ↗ |
| K011491 | HELIOSEAL CLEAR CHROMA | Ivoclar North America, Inc. | 2001-08-16 | Traditional | PDF ↗ |
| K011822 | PIT AND FISSURE CHEMICAL CURING SEALANT | Rite-Dent Manufacturing Corp. | 2001-08-07 | Traditional | PDF ↗ |
| K993846 | ULTRASEAL XT PLUS | Ultradent Products, Inc. | 2000-02-16 | Traditional | PDF ↗ |
| K992519 | NRC NON-RINSE CONDITIONER | Dentsply Intl. | 1999-10-22 | Traditional | PDF ↗ |
| K992326 | 3M CLINPRO SEALANT | 3M Company | 1999-10-08 | Traditional | PDF ↗ |
| K992518 | PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM | Dentsply Intl. | 1999-09-22 | Traditional | PDF ↗ |
| K992516 | DYRACT SEAL COMPOMER PIT & FISSURE SEALANT | Dentsply Intl. | 1999-08-27 | Traditional | PDF ↗ |
| K991909 | DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT | Dentsply Intl. | 1999-08-20 | Traditional | PDF ↗ |
| K991902 | LC PIT & FISSURE SEALANT | Bosworth Co. | 1999-07-26 | Traditional | PDF ↗ |
| K991099 | AMERICAN DENTAL PRODUCTS ETCH-DETECT | American Dental Products, Inc. | 1999-06-10 | Traditional | PDF ↗ |
| K990650 | CONSEAL F | Southern Dental Industries, Inc. | 1999-05-14 | Traditional | PDF ↗ |
| K990306 | HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 | Kay See Dental Mfg. Co. | 1999-03-03 | Traditional | PDF ↗ |
| K982564 | DELTON FS DIRECT DELIVERY SYSTEM | Dentsply Intl. | 1998-10-06 | Traditional | PDF ↗ |
| K973541 | MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED | Medental Intl. | 1997-11-25 | Traditional | PDF ↗ |
| K965091 | TEETHMATE F-1 | Kuraray Company, Ltd. | 1997-03-27 | Traditional | PDF ↗ |
| K963921 | PULPDENT SEAL-RITE UDMA | Pulpdent Corp. | 1996-11-12 | Traditional | PDF ↗ |
| K961190 | GLY-ETCH | Centrix, Inc. | 1996-04-23 | Traditional | PDF ↗ |
| K954867 | IONOSIT SEAL | Foremost Dental Mfg., Inc. | 1996-03-08 | Traditional | PDF ↗ |
| K954827 | SEALITE FL | Sybron Dental Specialties, Inc. | 1996-01-04 | Traditional | PDF ↗ |
| K954701 | AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING | American Dental Products, Inc. | 1995-10-30 | Traditional | PDF ↗ |
| K952240 | TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION | Jeneric/Pentron, Inc. | 1995-08-18 | Traditional | PDF ↗ |
| K951296 | DELTON F PIT & FISSURE SEALANT | Dentsply Intl. | 1995-05-03 | Traditional | PDF ↗ |
| K945378 | PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT | Pulpdent Corp. | 1995-01-17 | Traditional | PDF ↗ |
| K935727 | P&FS PIT AND FISSURE SEALANT | Jedental Co., Inc. | 1994-01-21 | Traditional | PDF ↗ |
| K932794 | PULPDENT SEAL-RITE LOW VISCOSITY | Pulpdent Corp. | 1993-09-20 | Traditional | PDF ↗ |
| K932078 | HELIOSEAL F | Ivoclar North America, Inc. | 1993-09-15 | Traditional | PDF ↗ |
| K931868 | PRIMADRY PRODUCT LINE | Ultradent Products, Inc. | 1993-07-22 | Traditional | PDF ↗ |
| K932002 | BARITONE C2, MODIFICATION | Confi-Dental Products Co. | 1993-07-22 | Traditional | PDF ↗ |
| K931857 | SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT | Confi-Dental Products Co. | 1993-07-22 | Traditional | PDF ↗ |
| K931869 | ULTRASEAL XT PIT AND FISSURE SEALANT PRODUCT LINE | Ultradent Products, Inc. | 1993-07-22 | Traditional | PDF ↗ |
| K924824 | MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE | Unicep | 1993-03-16 | Traditional | PDF ↗ |
| K923895 | QUIKSEAL | Mirage Dental Systems | 1992-12-23 | Traditional | PDF ↗ |
| K924635 | ALPHA-DENT PIT AND FISSURE SEALANT | Wallace A. Erickson & Co. | 1992-10-16 | Traditional | PDF ↗ |
| K921599 | ULTRADENT PRODUCT DENTIN CONDITION & SEAL PROD LIN | Ultradent Products, Inc. | 1992-09-28 | Traditional | PDF ↗ |
| K921600 | ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE | Ultradent Products, Inc. | 1992-09-28 | Traditional | PDF ↗ |
| K913853 | FISSURE SEALER | Ortho Source | 1992-08-27 | Traditional | PDF ↗ |
| K915095 | ESTISEAL LC | Heraeus Kulzer, Inc. | 1992-01-17 | Traditional | PDF ↗ |
| K914322 | BARITONE C2 & BARITONE L3 | Confi-Dental Products Co. | 1991-10-23 | Traditional | PDF ↗ |
| K914319 | PIT AND FISSURE SEALANT PRODUCTS | Confi-Dental Products Co. | 1991-10-23 | Traditional | PDF ↗ |
| K911287 | PULPDENT SEAL RITE | Pulpdent Corp. | 1991-06-10 | Traditional | PDF ↗ |
| K910813 | MET-ETCH | Gresco Products, Inc. | 1991-05-07 | Traditional | PDF ↗ |
| K905582 | POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND | Milton Hodosh, M.D. | 1991-04-29 | Traditional | PDF ↗ |
| K902742 | DEGUFILL (TM) WHIT-SEALANT | Degussa AG | 1990-09-12 | Traditional | PDF ↗ |
| K902022 | SEAL RITE(TM) | Pulpdent Corp. | 1990-07-20 | Traditional | PDF ↗ |
| K902023 | SEAL RITE PROCEDURE KIT(TM) | Pulpdent Corp. | 1990-07-13 | Traditional | PDF ↗ |
| K896341 | FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE | Dentsply Intl. | 1990-04-23 | Traditional | PDF ↗ |
| K897027 | TEETHMATE-A | Kuraray Co. | 1990-03-14 | Traditional | PDF ↗ |
| K891140 | OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT | Coe Laboratories, Inc. | 1989-05-01 | Traditional | PDF ↗ |
| K890494 | FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS | Macrochem Corp. | 1989-03-29 | Traditional | PDF ↗ |
| K890464 | ZENITH 40% PHOSPHORIC ACID GEL | Foremost Dental Mfg., Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K875091 | ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT | Mission White Dental, Inc. | 1988-02-29 | Traditional | PDF ↗ |
| K874944 | MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT | Dentsply Intl. | 1988-02-08 | Traditional | PDF ↗ |
| K874557 | BISCO PORCELAIN REPAIR KIT | Bisco, Inc. | 1988-01-28 | Traditional | PDF ↗ |
| K874556 | BISCO PIT AND FISSURE SEALANT | Bisco, Inc. | 1988-01-28 | Traditional | PDF ↗ |
| K873069 | MODIFIED VISIO-SEAL | Espe GmbH (Us) | 1987-09-15 | Traditional | PDF ↗ |
Product code EBC · Class II · Dental. Data: openFDA.