OIV — Dental Amalgam Class II

FDA Device Classification

Classification Details

Product Code
OIV
Device Class
Class II
Regulation Number
872.3070
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K223182worldworkArial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2May 1, 2023
K140125new steticNEW STETIC DENTAL AMALGAM ALLOYApril 29, 2014
K081273sdiULTRACAPS SJuly 10, 2008