DeviceClearance

Product code OIV— Dental

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

Classification name
Dental Amalgam
Device class
Class 2
Regulation
21 CFR 872.3070
Advisory panel
Dental
Total cleared
3
First cleared
Most recent

FDA classification 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”

— U.S. Food and Drug Administration, device classification record for product code OIV under 21 CFR 872.3070, via openFDA

Market context for product code OIV

FDA has cleared 3 devices under product code OIV between 2008 and 2023, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OIV

Recent clearances under product code OIV

Data sourced from openFDA. This site is unofficial and independent of the FDA.