510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OIVClass II

Dental Amalgam

21 CFR 872.3070 / Dental
FDA source (opens on fda.gov)

OIV is the FDA product code for Dental Amalgam, a class II device type, regulated under 21 CFR 872.3070. FDA's definition for this code reads: "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". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OIV
Device name
Dental Amalgam
FDA 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
Regulation
21 CFR 872.3070
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code OIV

By decision year
3 clearances under product code OIV with a decision year between 2008 and 2023, 2008 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OIV by decision year
YearClearances
20081
20141
20231

Applicants with the most clearances

Product code OIV
Applicants holding the most 510(k) clearances under product code OIV
ApplicantClearances
New Stetic1
Sdi, Ltd.1
Worldwork S.R.L1

Companies listing this code with FDA

Companies whose registered establishments list this code