EBD · Class II · 21 CFR 872.3310

FDA Product Code EBD: Coating, Filling Material, Resin

Leading manufacturers include Bisco, Inc., Scientific Pharmaceuticals, Inc. and 3M Company.

52
Total
52
Cleared
87d
Avg days
1976
Since
Growing category - 3 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 152d recently vs 83d historically

FDA 510(k) Cleared Coating, Filling Material, Resin Devices (Product Code EBD)

52 devices
1–24 of 52
Cleared Apr 06, 2026
GLOSSY COAT (15ML)
K254091
YAMAHACHI DENTAL MFG., Co.
Dental · 108d
Cleared Jun 04, 2025
ID LIGHT CURE SYSTEM
K250804
Id Korea Co., Ltd.
Dental · 79d
Cleared Dec 12, 2024
visio.lign color, visio.lign shield
K240735
Bredent GmbH & Co. KG
Dental · 269d
Cleared Mar 27, 2023
RODIN Palette Naturalizing Kit
K223365
Belport Company, Inc., Gingi-Pak
Dental · 144d
Cleared Nov 22, 2021
VITA Akzent LC
K211854
Vita Zahnfabrik GmbH H Rauter & CO
Dental · 159d
Cleared Apr 05, 2018
Nano Varnish, Plaquit, Lightpaint on Surface
K162408
Dreve Dentamid GmbH
Dental · 584d
Cleared Aug 16, 2017
SHOFU RESIN GLAZE
K163568
Shofu Dental Corporation
Dental · 240d
Cleared Mar 06, 2014
OPTIGLAZE COLOR
K133836
GC America, Inc.
Dental · 78d
Cleared Oct 24, 2008
EASY GLAZE
K082285
Voco GmbH
Dental · 74d
Cleared May 13, 2008
DURAFINISH ALL-CURE, MODEL S296
K080549
Parkell, Inc.
Dental · 76d
Cleared Mar 22, 2007
PAINT- ON POLISH AGENT
K070306
Dentsply International, Inc.
Dental · 49d
Cleared Oct 20, 2005
G-COAT
K052462
GC America, Inc.
Dental · 42d
Cleared Aug 22, 2005
BISCOVER LED
K051999
Bisco, Inc.
Dental · 28d
Cleared Feb 01, 2005
BISCOVER LV
K043168
Bisco, Inc.
Dental · 77d
Cleared Apr 09, 2004
PARKELL RESIN GLAZE
K040599
Parkell, Inc.
Dental · 32d
Cleared Apr 28, 2003
SCULPTING RESIN
K030585
Bisco, Inc.
Dental · 63d
Cleared Feb 19, 2003
BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER
K030354
Bisco, Inc.
Dental · 16d
Cleared Feb 06, 2003
TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P
K024046
Bisco, Inc.
Dental · 62d
Cleared Aug 01, 2002
UNINHIBITED
K021503
Bisco, Inc.
Dental · 84d
Cleared Apr 19, 1990
NO-STICK COMPOSITE INSTRUMENT DIP
K901050
Pulpdent Corp.
Dental · 45d
Cleared Jul 22, 1986
3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS)
K862590
3M Company
Dental · 15d
Cleared Aug 19, 1985
ESPE KETAC-BOND
K844845
Espe GmbH (Us)
Dental · 249d
Cleared Mar 25, 1985
CURAY JOIN DENT DENTIN PRIMER
K850675
Scientific Pharmaceuticals, Inc.
Dental · 32d
Cleared Mar 18, 1985
CAULK DYCAL LIGHT CURED
K850641
Dentsply Intl.
Dental · 27d

About Product Code EBD - Regulatory Context

510(k) Submission Activity

52 total 510(k) submissions under product code EBD since 1976, with 52 receiving FDA clearance (average review time: 87 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - EBD Product Code

Recent submissions under EBD have taken an average of 152 days to reach a decision - up from 83 days historically. Manufacturers should account for longer review timelines in current project planning.

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