FDA product code EIT: Applicator, Rapid Wax, Dental
EIT is the FDA product code for applicator, rapid wax, dental. It is a Class II device, regulated under 21 CFR 872.3060 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under EIT. The average 510(k) review took 30 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Applicator, Rapid Wax, Dental |
| Device class | Class II |
| Regulation | 21 CFR 872.3060 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EIT clearance
Top EIT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Argen Precious Metals, Inc. | 1 | 1990-10-31 |
Most recent EIT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K904467 | Argen Precious Metals, Inc. | ARGILITE 3 | 1990-10-31 | 30 |
Recalls for EIT devices
openFDA lists no recalls for product code EIT.
Frequently asked questions
What is FDA product code EIT?
EIT is the FDA product code for applicator, rapid wax, dental. It is a Class II device, regulated under 21 CFR 872.3060 and reviewed by the Dental panel.
What device class is EIT?
Class II, regulation 21 CFR 872.3060. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EIT?
Across 1 cleared submissions the average was 30 days from receipt to decision (median 30).
Which companies have the most EIT clearances?
Argen Precious Metals, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EIT
- Run a recall and safety report across every EIT manufacturer
- Watch product code EIT 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.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times