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 Sdi , Ltd., New Stetic and 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
Cleared
May 01, 2023
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
Worldwork S.R.L
Dental
202d
Cleared
Apr 29, 2014
NEW STETIC DENTAL AMALGAM ALLOY
New Stetic
Dental
103d
Cleared
Jul 10, 2008
ULTRACAPS S
Sdi , Ltd.
Dental
66d
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.