Atlas FDA

EBC

131 FDA 510(k) clearances · Product code

70 daysmedian time to decision
165 days90th percentile
131clearances measured

FDA profile

Official device name
Sealant, Pit And Fissure, And Conditioner
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3765
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2003: 1 · 2004: 4 · 2006: 5 · 2007: 3 · 2011: 5 · 2013: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Any-Com Seal (K260819)Mediclus Co., Ltd.2026-05-01
Parkell Pit and Fissure Sealant (K243254)Parkell, Inc.2025-08-08
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio (K232498)Ultradent Product, Inc.2023-08-18
Enamel Coating Resin (K230455)Rizhao Huge Biomaterials Company, Ltd.2023-07-25
BA Pit & Fissure Sealant (K190998)Apex Dental Materials, Inc.2019-11-08
Helioseal F Plus (K190339)Ivoclar Vivadent, AG2019-07-29
Pulpdent (Activa) Pit and Fissure Sealant with MCP (K172169)Pulpdent Corporation2018-01-05
Nanova Sealant (K171330)Nanova Biomaterials, Inc.2017-09-08
HAPI Seal (K162598)Bisco, Inc.2017-05-23
Premier Sealant (K161580)Premier Dental Company Products2016-10-18
PACSEAL PIT & FISSURE SEALANT (K141717)Pac-Dent International, Inc.2015-03-09
CONTROL SEAL (K130485)Voco GmbH2014-02-11
PREVENT SEAL (K122521)Itena Clinical2013-06-11
EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL (K113818)Pulpdent Corporation2012-03-21
ULTRASEAL XT HYDRO (K112517)Ultradent Products, Inc.2011-09-23
BEAUTISEALANT (K111782)Shofu Dental Corporation2011-09-16
BPA-FREE PIT AND FISSURE SEALANT (K110058)Novocol Inc. Dba Septodont and Confi-Dental Produc2011-03-31
DMP PIT & FISSURE SEALANT (K102252)Dmp, Ltd.2010-12-03
ECO-S (K103121)Vericom Co., Ltd.2010-10-26
ULTRASEAL ID (K101245)Ultradent Products, Inc.2010-09-17
INFILTRATION KIT (K100062)Dmg USA, Inc.2010-03-26
SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT (K093059)Classone Orthodontics, Inc.2010-02-04
SPK SEALANT (K091632)3M Company2009-09-03
CLEAR BRAVO (K083473)Denali R&D Corporation2009-01-22
INFILTRATION KIT (K081493)Dmg USA, Inc.2008-09-18
AURALAY PIT & FISSURE SEALANT (K071158)Denali Corporation2007-06-05
ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 (K062886)CAO Group, Inc.2006-11-06
PREMIER SELF-ETCHING ENAMEL SEALANT (K061997)Premier Dental Products Co.2006-10-04
GRANDIO SEAL (K062344)Voco GmbH2006-10-02
ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE (K061823)Voco GmbH2006-07-21
EMBRACE WETBOND CLEAR SEALANT (K052281)Pulpdent Corporation2006-02-08
ASCENT PIT & FISSURE SEALANT (K053089)CAO Group, Inc.2005-12-20
BOSWORTH SEAL (K051224)Harry J. Bosworth Co.2005-07-28
RIVA PROTECT (K050871)Southern Dental Industries, Inc.2005-06-10
DELTON ILLUMINATING PIT AND FISSURE SEALING (K050959)Dentsply International2005-05-11
COSMEDENT PIT & FISSURE SEALANT (K042823)Cosmedent, Inc.2004-12-01
AEGIS PIT & FISSURE SEALANT WITH ACP (K033751)Harry J. Bosworth Co.2004-02-05
PIT & FISSURE SEALANT WITH FLUORIDE (K031811)Harry J. Bosworth Co.2003-09-04
ADMIRA SEAL (K021842)Voco GmbH2002-07-29
ADMIRA PROTECT (K021844)Voco GmbH2002-07-19
DENTITION INTEGRATING MATERIAL (K020287)Pulpdent Corporation2002-04-12
PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT (K012761)Prime Dental Manufacturing, Inc.2001-11-01
REVOTEK LC (K012542)GC America, Inc.2001-10-16
TEETHMATE F-1 (K012742)Kuraray Medical, Inc.2001-09-14
OPTIBOND SOLO PLUS 3 (K011908)Kerr Dental Materials Center2001-09-06
HELIOSEAL CLEAR CHROMA (K011491)Ivoclar North America, Inc.2001-08-16
PIT AND FISSURE CHEMICAL CURING SEALANT (K011822)Rite-Dent Manufacturing Corp.2001-08-07
ULTRASEAL XT PLUS (K993846)Ultradent Products, Inc.2000-02-16
NRC NON-RINSE CONDITIONER (K992519)Dentsply Intl.1999-10-22
3M CLINPRO SEALANT (K992326)3M Company1999-10-08
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM (K992518)Dentsply Intl.1999-09-22
DYRACT SEAL COMPOMER PIT & FISSURE SEALANT (K992516)Dentsply Intl.1999-08-27
DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT (K991909)Dentsply Intl.1999-08-20
LC PIT & FISSURE SEALANT (K991902)Bosworth Co.1999-07-26
AMERICAN DENTAL PRODUCTS ETCH-DETECT (K991099)American Dental Products, Inc.1999-06-10
CONSEAL F (K990650)Southern Dental Industries, Inc.1999-05-14
HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 (K990306)Kay See Dental Mfg. Co.1999-03-03
DELTON FS DIRECT DELIVERY SYSTEM (K982564)Dentsply Intl.1998-10-06
MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED (K973541)Medental Intl.1997-11-25
TEETHMATE F-1 (K965091)Kuraray Company, Ltd.1997-03-27
PULPDENT SEAL-RITE UDMA (K963921)Pulpdent Corp.1996-11-12
GLY-ETCH (K961190)Centrix, Inc.1996-04-23
IONOSIT SEAL (K954867)Foremost Dental Mfg., Inc.1996-03-08
SEALITE FL (K954827)Sybron Dental Specialties, Inc.1996-01-04
AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING (K954701)American Dental Products, Inc.1995-10-30
TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION (K952240)Jeneric/Pentron, Inc.1995-08-18
DELTON F PIT & FISSURE SEALANT (K951296)Dentsply Intl.1995-05-03
PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT (K945378)Pulpdent Corp.1995-01-17
P&FS PIT AND FISSURE SEALANT (K935727)Jedental Co., Inc.1994-01-21
PULPDENT SEAL-RITE LOW VISCOSITY (K932794)Pulpdent Corp.1993-09-20
HELIOSEAL F (K932078)Ivoclar North America, Inc.1993-09-15
ULTRASEAL XT PIT AND FISSURE SEALANT PRODUCT LINE (K931869)Ultradent Products, Inc.1993-07-22
BARITONE C2, MODIFICATION (K932002)Confi-Dental Products Co.1993-07-22
PRIMADRY PRODUCT LINE (K931868)Ultradent Products, Inc.1993-07-22
SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT (K931857)Confi-Dental Products Co.1993-07-22
MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE (K924824)Unicep1993-03-16
QUIKSEAL (K923895)Mirage Dental Systems1992-12-23
ALPHA-DENT PIT AND FISSURE SEALANT (K924635)Wallace A. Erickson & Co.1992-10-16
ULTRADENT PRODUCT DENTIN CONDITION & SEAL PROD LIN (K921599)Ultradent Products, Inc.1992-09-28
ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE (K921600)Ultradent Products, Inc.1992-09-28
FISSURE SEALER (K913853)Ortho Source1992-08-27
ESTISEAL LC (K915095)Heraeus Kulzer, Inc.1992-01-17
PIT AND FISSURE SEALANT PRODUCTS (K914319)Confi-Dental Products Co.1991-10-23
BARITONE C2 & BARITONE L3 (K914322)Confi-Dental Products Co.1991-10-23
PULPDENT SEAL RITE (K911287)Pulpdent Corp.1991-06-10
MET-ETCH (K910813)Gresco Products, Inc.1991-05-07
POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND (K905582)Milton Hodosh, M.D.1991-04-29
DEGUFILL (TM) WHIT-SEALANT (K902742)Degussa AG1990-09-12
SEAL RITE(TM) (K902022)Pulpdent Corp.1990-07-20
SEAL RITE PROCEDURE KIT(TM) (K902023)Pulpdent Corp.1990-07-13
FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE (K896341)Dentsply Intl.1990-04-23
TEETHMATE-A (K897027)Kuraray Co.1990-03-14
OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT (K891140)Coe Laboratories, Inc.1989-05-01
FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS (K890494)Macrochem Corp.1989-03-29
ZENITH 40% PHOSPHORIC ACID GEL (K890464)Foremost Dental Mfg., Inc.1989-02-13
ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT (K875091)Mission White Dental, Inc.1988-02-29
MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT (K874944)Dentsply Intl.1988-02-08
BISCO PIT AND FISSURE SEALANT (K874556)Bisco, Inc.1988-01-28
BISCO PORCELAIN REPAIR KIT (K874557)Bisco, Inc.1988-01-28
MODIFIED VISIO-SEAL (K873069)Espe GmbH (Us)1987-09-15
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