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 May 23, 2017
HAPI Seal
K162598
Bisco, Inc.
Dental · 246d
Cleared Feb 11, 2014
CONTROL SEAL
K130485
Voco GmbH
Dental · 351d
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 Sep 17, 2010
ULTRASEAL ID
K101245
Ultradent Products, Inc.
Dental · 136d
Cleared Sep 03, 2009
SPK SEALANT
K091632
3M Company
Dental · 91d
Cleared Oct 04, 2006
PREMIER SELF-ETCHING ENAMEL SEALANT
K061997
Premier Dental Products Co.
Dental · 82d
Cleared Oct 02, 2006
GRANDIO SEAL
K062344
Voco GmbH
Dental · 52d
Cleared Jul 21, 2006
ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE
K061823
Voco GmbH
Dental · 23d
Cleared Jul 28, 2005
BOSWORTH SEAL
K051224
Harry J. Bosworth Co.
Dental · 77d
Cleared Feb 05, 2004
AEGIS PIT & FISSURE SEALANT WITH ACP
K033751
Harry J. Bosworth Co.
Dental · 66d
Cleared Sep 04, 2003
PIT & FISSURE SEALANT WITH FLUORIDE
K031811
Harry J. Bosworth Co.
Dental · 84d
Cleared Jul 29, 2002
ADMIRA SEAL
K021842
Voco GmbH
Dental · 54d
Cleared Jul 19, 2002
ADMIRA PROTECT
K021844
Voco GmbH
Dental · 44d
Cleared Oct 16, 2001
REVOTEK LC
K012542
GC America, Inc.
Dental · 70d
Cleared Sep 14, 2001
TEETHMATE F-1
K012742
Kuraray Medical, Inc.
Dental · 31d
Cleared Aug 16, 2001
HELIOSEAL CLEAR CHROMA
K011491
Ivoclar North America, Inc.
Dental · 93d

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 →