FDA Product Code OIV: Dental Amalgam
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
Leading manufacturers include Worldwork S.R.L.
3
Total
3
Cleared
124d
Avg days
2008
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Dental Amalgam Devices (Product Code OIV)
3 devices
About Product Code OIV - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code OIV since 2008, with 3 receiving FDA clearance (average review time: 124 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
OIV devices are reviewed by the Dental panel. Browse all Dental devices →