EBC · Class II · 21 CFR 872.3765

FDA Product Code EBC: Sealant, Pit And Fissure, And Conditioner

Leading manufacturers include Dentsply Intl., 3M Company and Bisco, Inc..

131
Total
131
Cleared
81d
Avg days
1976
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg 173d recently vs 79d historically

FDA 510(k) Cleared Sealant, Pit And Fissure, And Conditioner Devices (Product Code EBC)

131 devices
1–24 of 131
Cleared May 01, 2026
Any-Com Seal
K260819
Mediclus Co., Ltd.
Dental · 49d
Cleared Aug 08, 2025
Parkell Pit and Fissure Sealant
K243254
Parkell, Inc.
Dental · 297d
Cleared Aug 18, 2023
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
K232498
Ultradent Product, Inc.
Dental · 1d
Cleared Jul 25, 2023
Enamel Coating Resin
K230455
Rizhao Huge Biomaterials Company, Ltd.
Dental · 154d
Cleared Nov 08, 2019
BA Pit & Fissure Sealant
K190998
Apex Dental Materials, Inc.
Dental · 206d
Cleared Jul 29, 2019
Helioseal F Plus
K190339
Ivoclar Vivadent, AG
Dental · 165d
Cleared Jan 05, 2018
Pulpdent (Activa) Pit and Fissure Sealant with MCP
K172169
Pulpdent Corporation
Dental · 171d
Cleared May 23, 2017
HAPI Seal
K162598
Bisco, Inc.
Dental · 246d
Cleared Sep 03, 2009
SPK SEALANT
K091632
3M Company
Dental · 91d
Cleared Oct 22, 1999
NRC NON-RINSE CONDITIONER
K992519
Dentsply Intl.
Dental · 86d
Cleared Oct 08, 1999
3M CLINPRO SEALANT
K992326
3M Company
Dental · 87d
Cleared Sep 22, 1999
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
K992518
Dentsply Intl.
Dental · 56d
Cleared Aug 27, 1999
DYRACT SEAL COMPOMER PIT & FISSURE SEALANT
K992516
Dentsply Intl.
Dental · 30d
Cleared Aug 20, 1999
DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT
K991909
Dentsply Intl.
Dental · 74d
Cleared Oct 06, 1998
DELTON FS DIRECT DELIVERY SYSTEM
K982564
Dentsply Intl.
Dental · 75d
Cleared May 03, 1995
DELTON F PIT & FISSURE SEALANT
K951296
Dentsply Intl.
Dental · 42d
Cleared Apr 23, 1990
FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE
K896341
Dentsply Intl.
Dental · 171d
Cleared Feb 08, 1988
MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT
K874944
Dentsply Intl.
Dental · 66d
Cleared Jul 31, 1986
PRISMA METAL OPAQUERS
K862660
Dentsply Intl.
Dental · 17d
Cleared Jan 09, 1985
PIT AND FISSURE SEAANTS
K844308
Dentsply Intl.
Dental · 64d
Cleared Jan 07, 1985
CONCISE LIGHT CURED WHITE SEALANT
K844211
3M Company
Dental · 68d
Cleared Nov 12, 1980
PRISMA SEAL
K802562
Dentsply Intl.
Dental · 27d

About Product Code EBC - Regulatory Context

510(k) Submission Activity

131 total 510(k) submissions under product code EBC since 1976, with 131 receiving FDA clearance (average review time: 81 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - EBC Product Code

Recent submissions under EBC have taken an average of 173 days to reach a decision - up from 79 days historically. Manufacturers should account for longer review timelines in current project planning.

EBC devices are reviewed by the Dental panel. Browse all Dental devices →