FDA product code EMK: Curette, Surgical, Dental
EMK is the FDA product code for curette, surgical, dental. 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 EMK. The average 510(k) review took 68 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Curette, Surgical, Dental |
| Device class | Class I |
| Regulation | 21 CFR 872.4565 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Top EMK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Artiberia | 1 | 1985-07-02 |
Most recent EMK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851718 | Artiberia | 930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTES | 1985-07-02 | 68 |
Recalls for EMK devices
openFDA lists no recalls for product code EMK.
Frequently asked questions
What is FDA product code EMK?
EMK is the FDA product code for curette, surgical, dental. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EMK?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EMK?
Across 1 cleared submissions the average was 68 days from receipt to decision (median 68).
Which companies have the most EMK clearances?
Artiberia (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EMK
- Run a recall and safety report across every EMK manufacturer
- Watch product code EMK 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.