OIVClass II
Dental Amalgam
Dental · 21 CFR 872.3070
Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth
MDR events34All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances3All time
Recent MDR events
34 adverse event reports on file
- DENTAL AMALGAMMar 19, 2024InjuryUnknownMW5153010
- MERCURY AMALGAMNov 16, 2023InjuryUnknownMW5148254
- AMALGAM FILLINGSOct 30, 2023InjuryUnknownMW5147509
- AMALGAM FILLINGSOct 30, 2023InjuryUnknownMW5147510
- AMALGAM FILLINGSOct 30, 2023InjuryUnknownMW5147511
- AMALGAM FILLINGSOct 30, 2023InjuryUnknownMW5147512
- DENTAL AMALGAM FILLINGSep 8, 2023InjuryUnkMW5145366
- DENTAL AMALGAM FILLINGSJun 12, 2023InjuryUnkMW5118362
- MERCURY SILVER AMALGAMJun 2, 2023InjuryUnkMW5118146
- DENTAL AMALGAMAug 16, 2022InjuryUnkMW5111540
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
3 clearances for this product code
- Worldwork S.R.LMay 1, 2023
K223182 · Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy
- New SteticApr 29, 2014
K140125 · NEW STETIC DENTAL AMALGAM ALLOY
- Sdi , Ltd.Jul 10, 2008
K081273 · ULTRACAPS S