FDA product code EIR: Scissors, Collar And Crown
EIR is the FDA product code for scissors, collar and crown. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under EIR. The average 510(k) review took 68 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Scissors, Collar And Crown |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EIR clearance
Top EIR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Artiberia | 1 | 1985-07-02 |
Most recent EIR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851729 | Artiberia | 2620/1 TO 2635/2 VARIOUS DENTAL CROWN SCISSORS | 1985-07-02 | 68 |
Recalls for EIR devices
openFDA lists no recalls for product code EIR.
Frequently asked questions
What is FDA product code EIR?
EIR is the FDA product code for scissors, collar and crown. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EIR?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EIR?
Across 1 cleared submissions the average was 68 days from receipt to decision (median 68).
Which companies have the most EIR clearances?
Artiberia (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EIR
- Run a recall and safety report across every EIR manufacturer
- Watch product code EIR 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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