EBC · Class II · 21 CFR 872.3765

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

Leading manufacturers include Dentsply Intl., Ultradent Products, Inc. and Pulpdent Corp..

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 Sep 08, 2017
Nanova Sealant
K171330
Nanova Biomaterials, Inc.
Dental · 126d
Cleared May 23, 2017
HAPI Seal
K162598
Bisco, Inc.
Dental · 246d
Cleared Oct 18, 2016
Premier Sealant
K161580
Premier Dental Company Products
Dental · 132d
Cleared Mar 09, 2015
PACSEAL PIT & FISSURE SEALANT
K141717
Pac-Dent International, Inc.
Dental · 257d
Cleared Feb 11, 2014
CONTROL SEAL
K130485
Voco GmbH
Dental · 351d
Cleared Jun 11, 2013
PREVENT SEAL
K122521
Itena Clinical
Dental · 295d
Cleared Mar 21, 2012
EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL
K113818
Pulpdent Corporation
Dental · 85d
Cleared Sep 23, 2011
ULTRASEAL XT HYDRO
K112517
Ultradent Products, Inc.
Dental · 23d
Cleared Sep 16, 2011
BEAUTISEALANT
K111782
Shofu Dental Corporation
Dental · 84d
Cleared Mar 31, 2011
BPA-FREE PIT AND FISSURE SEALANT
K110058
Novocol Inc. Dba Septodont and Confi-Dental Produc
Dental · 80d
Cleared Oct 26, 2010
ECO-S
K103121
Vericom Co., Ltd.
Dental · 4d
Cleared Sep 17, 2010
ULTRASEAL ID
K101245
Ultradent Products, Inc.
Dental · 136d
Cleared Mar 26, 2010
INFILTRATION KIT
K100062
Dmg USA, Inc.
Dental · 74d
Cleared Sep 03, 2009
SPK SEALANT
K091632
3M Company
Dental · 91d
Cleared Sep 18, 2008
INFILTRATION KIT
K081493
Dmg USA, Inc.
Dental · 113d
Cleared Nov 06, 2006
ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019
K062886
CAO Group, Inc.
Dental · 41d
Cleared Oct 04, 2006
PREMIER SELF-ETCHING ENAMEL SEALANT
K061997
Premier Dental Products Co.
Dental · 82d

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 →