Product Code: EBC FDA class 2 21 CFR 872.3765

Sealant, Pit And Fissure, And Conditioner

Dental

The Pit and Fissure Sealant and Conditioner is a dental preventive device consisting of a resinous material applied to the occlusal surfaces of posterior teeth to seal the grooves and pits where bacteria accumulate, reducing the incidence of caries, along with an acid conditioner that prepares the enamel surface for bonding. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is EBC and the applicable regulation is 21 CFR 872.3765, under the Dental medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

131

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code EBC in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: EBC
Device Class: FDA class 2
Regulation Number: 872.3765
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 131 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260819	Any-Com Seal	May 01, 2026	Substantially Equivalent	Mediclus Co., Ltd.
K243254	Parkell Pit and Fissure Sealant	Aug 08, 2025	Substantially Equivalent	Parkell, Inc.
K232498	UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio	Aug 18, 2023	Substantially Equivalent	Ultradent Product, Inc.
K230455	Enamel Coating Resin	Jul 25, 2023	Substantially Equivalent	Rizhao Huge Biomaterials Company, Ltd.
K190998	BA Pit & Fissure Sealant	Nov 08, 2019	Substantially Equivalent	Apex Dental Materials, Inc.
K190339	Helioseal F Plus	Jul 29, 2019	Substantially Equivalent	Ivoclar Vivadent, AG
K172169	Pulpdent (Activa) Pit and Fissure Sealant with MCP	Jan 05, 2018	Substantially Equivalent	Pulpdent Corporation
K171330	Nanova Sealant	Sep 08, 2017	Substantially Equivalent	Nanova Biomaterials, Inc.
K162598	HAPI Seal	May 23, 2017	Substantially Equivalent	Bisco, Inc.
K161580	Premier Sealant	Oct 18, 2016	Substantially Equivalent	Premier Dental Company Products
K141717	PACSEAL PIT & FISSURE SEALANT	Mar 09, 2015	Substantially Equivalent	Pac-Dent International, Inc.
K130485	CONTROL SEAL	Feb 11, 2014	Substantially Equivalent	Voco GmbH
K122521	PREVENT SEAL	Jun 11, 2013	Substantially Equivalent	Itena Clinical
K113818	EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL	Mar 21, 2012	Substantially Equivalent	Pulpdent Corporation
K112517	ULTRASEAL XT HYDRO	Sep 23, 2011	Substantially Equivalent	Ultradent Products, Inc.
K111782	BEAUTISEALANT	Sep 16, 2011	Substantially Equivalent	Shofu Dental Corporation
K110058	BPA-FREE PIT AND FISSURE SEALANT	Mar 31, 2011	Substantially Equivalent	Novocol Inc. Dba Septodont and Confi-Dental Produc
K102252	DMP PIT & FISSURE SEALANT	Dec 03, 2010	Substantially Equivalent	Dmp, Ltd.
K103121	ECO-S	Oct 26, 2010	Substantially Equivalent	Vericom Co., Ltd.
K101245	ULTRASEAL ID	Sep 17, 2010	Substantially Equivalent	Ultradent Products, Inc.
K100062	INFILTRATION KIT	Mar 26, 2010	Substantially Equivalent	Dmg USA, Inc.
K093059	SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT	Feb 04, 2010	Substantially Equivalent	Classone Orthodontics, Inc.
K091632	SPK SEALANT	Sep 03, 2009	Substantially Equivalent	3M Company
K083473	CLEAR BRAVO	Jan 22, 2009	Substantially Equivalent	Denali R&D Corporation
K081493	INFILTRATION KIT	Sep 18, 2008	Substantially Equivalent	Dmg USA, Inc.
K071158	AURALAY PIT & FISSURE SEALANT	Jun 05, 2007	Substantially Equivalent	Denali Corporation
K062886	ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019	Nov 06, 2006	Substantially Equivalent	CAO Group, Inc.
K061997	PREMIER SELF-ETCHING ENAMEL SEALANT	Oct 04, 2006	Substantially Equivalent	Premier Dental Products Co.
K062344	GRANDIO SEAL	Oct 02, 2006	Substantially Equivalent	Voco GmbH
K061823	ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE	Jul 21, 2006	Substantially Equivalent	Voco GmbH
K052281	EMBRACE WETBOND CLEAR SEALANT	Feb 08, 2006	Substantially Equivalent	Pulpdent Corporation
K053089	ASCENT PIT & FISSURE SEALANT	Dec 20, 2005	Substantially Equivalent	CAO Group, Inc.
K051224	BOSWORTH SEAL	Jul 28, 2005	Substantially Equivalent	Harry J. Bosworth Co.
K050871	RIVA PROTECT	Jun 10, 2005	Substantially Equivalent	Southern Dental Industries, Inc.
K050959	DELTON ILLUMINATING PIT AND FISSURE SEALING	May 11, 2005	Substantially Equivalent	Dentsply International
K042823	COSMEDENT PIT & FISSURE SEALANT	Dec 01, 2004	Substantially Equivalent	Cosmedent, Inc.
K033751	AEGIS PIT & FISSURE SEALANT WITH ACP	Feb 05, 2004	Substantially Equivalent	Harry J. Bosworth Co.
K031811	PIT & FISSURE SEALANT WITH FLUORIDE	Sep 04, 2003	Substantially Equivalent	Harry J. Bosworth Co.
K021842	ADMIRA SEAL	Jul 29, 2002	Substantially Equivalent	Voco GmbH
K021844	ADMIRA PROTECT	Jul 19, 2002	Substantially Equivalent	Voco GmbH
K020287	DENTITION INTEGRATING MATERIAL	Apr 12, 2002	Substantially Equivalent	Pulpdent Corporation
K012761	PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT	Nov 01, 2001	Substantially Equivalent	Prime Dental Manufacturing, Inc.
K012542	REVOTEK LC	Oct 16, 2001	Substantially Equivalent	GC America, Inc.
K012742	TEETHMATE F-1	Sep 14, 2001	Substantially Equivalent	Kuraray Medical, Inc.
K011908	OPTIBOND SOLO PLUS 3	Sep 06, 2001	Substantially Equivalent	Kerr Dental Materials Center
K011491	HELIOSEAL CLEAR CHROMA	Aug 16, 2001	Substantially Equivalent	Ivoclar North America, Inc.
K011822	PIT AND FISSURE CHEMICAL CURING SEALANT	Aug 07, 2001	Substantially Equivalent	Rite-Dent Manufacturing Corp.
K993846	ULTRASEAL XT PLUS	Feb 16, 2000	Substantially Equivalent	Ultradent Products, Inc.
K992519	NRC NON-RINSE CONDITIONER	Oct 22, 1999	Substantially Equivalent	Dentsply Intl.
K992326	3M CLINPRO SEALANT	Oct 08, 1999	Substantially Equivalent	3M Company
K992518	PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM	Sep 22, 1999	Substantially Equivalent	Dentsply Intl.
K992516	DYRACT SEAL COMPOMER PIT & FISSURE SEALANT	Aug 27, 1999	Substantially Equivalent	Dentsply Intl.
K991909	DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT	Aug 20, 1999	Substantially Equivalent	Dentsply Intl.
K991902	LC PIT & FISSURE SEALANT	Jul 26, 1999	Substantially Equivalent	Bosworth Co.
K991099	AMERICAN DENTAL PRODUCTS ETCH-DETECT	Jun 10, 1999	Substantially Equivalent	American Dental Products, Inc.
K990650	CONSEAL F	May 14, 1999	Substantially Equivalent	Southern Dental Industries, Inc.
K990306	HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025	Mar 03, 1999	Substantially Equivalent	Kay See Dental Mfg. Co.
K982564	DELTON FS DIRECT DELIVERY SYSTEM	Oct 06, 1998	Substantially Equivalent	Dentsply Intl.
K973541	MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED	Nov 25, 1997	Substantially Equivalent	Medental Intl.
K965091	TEETHMATE F-1	Mar 27, 1997	Substantially Equivalent	Kuraray Company, Ltd.
K963921	PULPDENT SEAL-RITE UDMA	Nov 12, 1996	Substantially Equivalent	Pulpdent Corp.
K961190	GLY-ETCH	Apr 23, 1996	Substantially Equivalent	Centrix, Inc.
K954867	IONOSIT SEAL	Mar 08, 1996	Substantially Equivalent	Foremost Dental Mfg., Inc.
K954827	SEALITE FL	Jan 04, 1996	Substantially Equivalent	Sybron Dental Specialties, Inc.
K954701	AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING	Oct 30, 1995	Substantially Equivalent	American Dental Products, Inc.
K952240	TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION	Aug 18, 1995	Substantially Equivalent	Jeneric/Pentron, Inc.
K951296	DELTON F PIT & FISSURE SEALANT	May 03, 1995	Substantially Equivalent	Dentsply Intl.
K945378	PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT	Jan 17, 1995	Substantially Equivalent	Pulpdent Corp.
K935727	P&FS PIT AND FISSURE SEALANT	Jan 21, 1994	Substantially Equivalent	Jedental Co., Inc.
K932794	PULPDENT SEAL-RITE LOW VISCOSITY	Sep 20, 1993	Substantially Equivalent	Pulpdent Corp.
K932078	HELIOSEAL F	Sep 15, 1993	Substantially Equivalent	Ivoclar North America, Inc.
K932002	BARITONE C2, MODIFICATION	Jul 22, 1993	Substantially Equivalent	Confi-Dental Products Co.
K931869	ULTRASEAL XT PIT AND FISSURE SEALANT PRODUCT LINE	Jul 22, 1993	Substantially Equivalent	Ultradent Products, Inc.
K931868	PRIMADRY PRODUCT LINE	Jul 22, 1993	Substantially Equivalent	Ultradent Products, Inc.
K931857	SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT	Jul 22, 1993	Substantially Equivalent	Confi-Dental Products Co.
K924824	MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE	Mar 16, 1993	Substantially Equivalent	Unicep
K923895	QUIKSEAL	Dec 23, 1992	Substantially Equivalent	Mirage Dental Systems
K924635	ALPHA-DENT PIT AND FISSURE SEALANT	Oct 16, 1992	Substantially Equivalent	Wallace A. Erickson & Co.
K921600	ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE	Sep 28, 1992	Substantially Equivalent	Ultradent Products, Inc.
K921599	ULTRADENT PRODUCT DENTIN CONDITION & SEAL PROD LIN	Sep 28, 1992	Substantially Equivalent	Ultradent Products, Inc.
K913853	FISSURE SEALER	Aug 27, 1992	Substantially Equivalent	Ortho Source
K915095	ESTISEAL LC	Jan 17, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K914322	BARITONE C2 & BARITONE L3	Oct 23, 1991	Substantially Equivalent	Confi-Dental Products Co.
K914319	PIT AND FISSURE SEALANT PRODUCTS	Oct 23, 1991	Substantially Equivalent	Confi-Dental Products Co.
K911287	PULPDENT SEAL RITE	Jun 10, 1991	Substantially Equivalent	Pulpdent Corp.
K910813	MET-ETCH	May 07, 1991	Substantially Equivalent	Gresco Products, Inc.
K905582	POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND	Apr 29, 1991	Substantially Equivalent	Milton Hodosh, M.D.
K902742	DEGUFILL (TM) WHIT-SEALANT	Sep 12, 1990	Substantially Equivalent	Degussa AG
K902022	SEAL RITE(TM)	Jul 20, 1990	Substantially Equivalent	Pulpdent Corp.
K902023	SEAL RITE PROCEDURE KIT(TM)	Jul 13, 1990	Substantially Equivalent	Pulpdent Corp.
K896341	FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE	Apr 23, 1990	Substantially Equivalent	Dentsply Intl.
K897027	TEETHMATE-A	Mar 14, 1990	Substantially Equivalent	Kuraray Co.
K891140	OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT	May 01, 1989	Substantially Equivalent	Coe Laboratories, Inc.
K890494	FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS	Mar 29, 1989	Substantially Equivalent	Macrochem Corp.
K890464	ZENITH 40% PHOSPHORIC ACID GEL	Feb 13, 1989	Substantially Equivalent	Foremost Dental Mfg., Inc.
K875091	ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT	Feb 29, 1988	Substantially Equivalent	Mission White Dental, Inc.
K874944	MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT	Feb 08, 1988	Substantially Equivalent	Dentsply Intl.
K874557	BISCO PORCELAIN REPAIR KIT	Jan 28, 1988	Substantially Equivalent	Bisco, Inc.
K874556	BISCO PIT AND FISSURE SEALANT	Jan 28, 1988	Substantially Equivalent	Bisco, Inc.
K873069	MODIFIED VISIO-SEAL	Sep 15, 1987	Substantially Equivalent	Espe GmbH (Us)
K870579	ALPHA-DENT PIT AND FISSURE SEALANT	Mar 02, 1987	Substantially Equivalent	Wallace A. Erickson & Co.
K862695	FLUOR-ETCH GEL ETCHANT	Jul 31, 1986	Substantially Equivalent	Teledyne, Inc.
K862660	PRISMA METAL OPAQUERS	Jul 31, 1986	Substantially Equivalent	Dentsply Intl.
K862284	SEALITE	Jun 23, 1986	Substantially Equivalent	Sybron Corp.
K861245	ORTHOSOURCE ETCH SYSTEMS	Apr 11, 1986	Substantially Equivalent	Ortho Source
K854882	PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT	Jan 30, 1986	Substantially Equivalent	Lee Pharmaceuticals
K854494	CERAM-ETCH	Dec 23, 1985	Substantially Equivalent	Gresco Products, Inc.
K845034	FOREMOST LITE CURE PIT & FISSURE SEALANT	Mar 18, 1985	Substantially Equivalent	Foremost Dental Mfg., Inc.
K844308	PIT AND FISSURE SEAANTS	Jan 09, 1985	Substantially Equivalent	Dentsply Intl.
K844211	CONCISE LIGHT CURED WHITE SEALANT	Jan 07, 1985	Substantially Equivalent	3M Company
K844057	C-22 PIT & FISSURE SEALANT	Dec 03, 1984	Substantially Equivalent	Pentron Corp.
K843024	COMMAND ULTRASEAL PIT & FISSURE SEALANT	Sep 27, 1984	Substantially Equivalent	Kerr Corporation (Danbury)
K843098	APCO FISSURE SEALER & BONDING AGENT	Sep 07, 1984	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K842392	DELTON * OPAQUE LIGHT CURING PIT	Jul 26, 1984	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K831380	DELTON LIGHT CURING PIT & FISSURE	Jun 30, 1983	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K813015	HELIOSEAL	Dec 02, 1981	Substantially Equivalent	Vivadent (Usa), Inc.
K813091	FISSURE SEALER & BONDING AGENT	Nov 24, 1981	Substantially Equivalent	Sci-Pharm, Inc.
K812549	BEAUSEAL	Sep 25, 1981	Substantially Equivalent	Sci-Pharm, Inc.
K811624	VISIO-SEAL	Jun 26, 1981	Substantially Equivalent	Espe-Premier Sales Co.
K810950	VISIO-SEAL	Apr 29, 1981	Substantially Equivalent	Espe Dental Products
K802682	CONTACT SEAL	Nov 24, 1980	Substantially Equivalent	Vivadent (Usa), Inc.
K802562	PRISMA SEAL	Nov 12, 1980	Substantially Equivalent	Dentsply Intl.
K801274	S.S. WHITE-PENNWALT PRELUDE PIT SEALANT	Jun 09, 1980	Substantially Equivalent	Pennwalt Corp.
K800391	PAINT-ON-RESTORATIVE W/FISSURE SEALER	Apr 10, 1980	Substantially Equivalent	American Dental Research
K790935	DELTON* PIT AND FISSURE SEALENT	Aug 03, 1979	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K790788	FISSURE SEALER AND BONDING AGENT	Jul 06, 1979	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K790596	ENAMEL BOND SYSTEM	Jun 15, 1979	Substantially Equivalent	Wallace A. Erickson & Co.
K771402	NUVA-COTE (MODIFICATION TO)	Aug 26, 1977	Substantially Equivalent	L.D. Caulk Co.
K771327	UVIOFIL	Aug 02, 1977	Substantially Equivalent	Espe GmbH (Us)
K760418	9075	Aug 23, 1976	Substantially Equivalent	Lee Pharmaceuticals
K760405	SEALANT, NEW FILLED	Aug 23, 1976	Substantially Equivalent	L.D. Caulk Co.