FDA product code EMR: File, Periodontic
EMR is the FDA product code for file, periodontic. 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 EMR. The average 510(k) review took 49 days (median 49).
Classification
| Field | Value |
|---|---|
| Device name | File, Periodontic |
| 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 EMR clearance
Top EMR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| North Pacific Dental, Inc. | 1 | 1983-03-01 |
Most recent EMR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K830109 | North Pacific Dental, Inc. | CIMPAT | 1983-03-01 | 49 |
Recalls for EMR devices
openFDA lists no recalls for product code EMR.
Frequently asked questions
What is FDA product code EMR?
EMR is the FDA product code for file, periodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EMR?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EMR?
Across 1 cleared submissions the average was 49 days from receipt to decision (median 49).
Which companies have the most EMR clearances?
North Pacific Dental, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EMR
- Run a recall and safety report across every EMR manufacturer
- Watch product code EMR 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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