Coating, Filling Material, Resin
Dental · 21 CFR 872.3310
Recent MDR events
13 adverse event reports on file
- UNKOWN DENTAL FILLINGMay 1, 2023InjuryUnknownMW5117172
- UNKOWN DENTAL FILLINGMay 1, 2023InjuryUnknownMW5117173
- UNKOWN DENTAL FILLINGMay 1, 2023InjuryUnknownMW5117174
- UNKOWN DENTAL FILLINGMay 1, 2023InjuryUnknownMW5117175
- UNKOWN DENTAL FILLINGMay 1, 2023InjuryUnknownMW5117176
- DENTAL FILLINGDec 20, 2021InjuryUnkMW5106207
- FILLING MATERIAL, TOOTHFeb 13, 2017InjuryUnkMW5067899
- DIAPEXMar 5, 2009InjuryBisco, Inc.1420052-2009-00001
- HELIOMOLAR CAVIFILMar 3, 2009InjuryIvoclar Vivadent, Inc.MW5010174
- VARIOUSJul 30, 2008MalfunctionMW5007852
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
66 firms currently registered for this product code
Bredent Gmbh & Co.kg
SENDEN Bavaria, DE
Cosmedent, Inc.
CHICAGO, IL, US
Kulzer Gmbh
HANAU Hesse, DE
Gc Asahi Corporation
AICHI, JP
Bisco, Inc.
Schaumburg, IL, US
Yamahachi Dental Mfg. Co.
Gamagori City Aichi, JP
Mainline Medical Dental Supply
North York Ontario, CA
Gc America Inc.
ALSIP, IL, US
Parkell, Inc.
EDGEWOOD, NY, US
Oketz Logistics Llc
Coral Gables, FL, US
Pulpdent Corporation
Watertown, MA, US
Scientific Pharmaceuticals, Inc.
POMONA, CA, US
M/s Leixir Resources Pvt. Ltd
GURUGRAM Haryana, IN
Ivoclar Vivadent Ag
SCHAAN, LI
Solventum Germany Gmbh
SEEFELD Bavaria, DE
Vita Zahnfabrik H. Rauter Gmbh & Co. Kg.
BAD SACKINGEN Baden-Wurttemberg, DE
Jersey Dental Supplies
Lakewood, NJ, US
Yamahachi Dental Material (changshu) Co., Ltd.
Changshu city Jiangsu, CN
Dentsply Llc
MILFORD, DE, US
Gc Corporation-fuji Oyama Factory
SUNTO-GUN, Shizuoka-Ken, JP
510(k) clearances
52 clearances for this product code
- YAMAHACHI DENTAL MFG., Co.Apr 6, 2026
K254091 · GLOSSY COAT (15ML)
- Id Korea Co., Ltd.Jun 4, 2025
K250804 · ID LIGHT CURE SYSTEM
- Bredent GmbH & Co. KGDec 12, 2024
K240735 · visio.lign color, visio.lign shield
- Belport Company, Inc., Gingi-PakMar 27, 2023
K223365 · RODIN Palette Naturalizing Kit
- Vita Zahnfabrik GmbH H Rauter & CONov 22, 2021
K211854 · VITA Akzent LC
- Dreve Dentamid GmbHApr 5, 2018
K162408 · Nano Varnish, Plaquit, Lightpaint on Surface
- Shofu Dental CorporationAug 16, 2017
K163568 · SHOFU RESIN GLAZE
- GC America, Inc.Mar 6, 2014
K133836 · OPTIGLAZE COLOR