FDA product code OIV: Dental Amalgam
OIV is the FDA product code for dental amalgam. It is a Class II device, regulated under 21 CFR 872.3070 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under OIV, 1 in the last five years, from 3 different applicants. The average 510(k) review took 124 days (median 103).
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
Classification
| Field | Value |
|---|---|
| Device name | Dental Amalgam |
| Device class | Class II |
| Regulation | 21 CFR 872.3070 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OIV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 202 |
Compare with all 510(k) review times · Search every OIV clearance
Top OIV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Worldwork S.R.L | 1 | 2023-05-01 |
| New Stetic | 1 | 2014-04-29 |
| Sdi , Ltd. | 1 | 2008-07-10 |
Most recent OIV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223182 | Worldwork S.R.L | 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 | 2023-05-01 | 202 |
| K140125 | New Stetic | NEW STETIC DENTAL AMALGAM ALLOY | 2014-04-29 | 103 |
| K081273 | Sdi , Ltd. | ULTRACAPS S | 2008-07-10 | 66 |
Recalls for OIV devices
openFDA lists no recalls for product code OIV.
Frequently asked questions
What is FDA product code OIV?
OIV is the FDA product code for dental amalgam. It is a Class II device, regulated under 21 CFR 872.3070 and reviewed by the Dental panel.
What device class is OIV?
Class II, regulation 21 CFR 872.3070. Typical premarket route: 510(k).
How long does a 510(k) take for product code OIV?
Across 3 cleared submissions the average was 124 days from receipt to decision (median 103).
Which companies have the most OIV clearances?
Worldwork S.R.L (1); New Stetic (1); Sdi , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OIV
- Run a recall and safety report across every OIV manufacturer
- Watch product code OIV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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