FDA product code EMS: Curette, Periodontic
EMS is the FDA product code for curette, periodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 7 510(k) submissions under EMS, from 6 different applicants. The average 510(k) review took 95 days (median 65).
Classification
| Field | Value |
|---|---|
| Device name | Curette, 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 EMS clearance
Top EMS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Military Engineering, Inc. | 2 | 1987-07-31 |
| Minnesota Prophy Power, Inc. | 1 | 1994-01-27 |
| Premier Dental Products Co. | 1 | 1984-06-15 |
| Venture Technology, Inc. | 1 | 1984-02-21 |
| Miltex, Inc. | 1 | 1982-11-24 |
1 more applicants have EMS clearances. See the full list in Caduvo.
Most recent EMS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K931329 | Minnesota Prophy Power, Inc. | DENTAL INSTRUMENTS CURETTE PERIODONTAL | 1994-01-27 | 317 |
| K872091 | Military Engineering, Inc. | CURRETTES, ALVEOLAR (MOLT AND MILLER) | 1987-07-31 | 60 |
| K870590 | Military Engineering, Inc. | CURETTE, PERIODONTAL, COLUMBIA UNIVERSITY | 1987-04-16 | 65 |
| K841011 | Premier Dental Products Co. | ELEVATOR - VARIOUS | 1984-06-15 | 98 |
| K834072 | Venture Technology, Inc. | INSTRUMENT, DENTAL | 1984-02-21 | 88 |
Recalls for EMS devices
openFDA lists no recalls for product code EMS.
Frequently asked questions
What is FDA product code EMS?
EMS is the FDA product code for curette, periodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EMS?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EMS?
Across 7 cleared submissions the average was 95 days from receipt to decision (median 65).
Which companies have the most EMS clearances?
Military Engineering, Inc. (2); Minnesota Prophy Power, Inc. (1); Premier Dental Products Co. (1); Venture Technology, Inc. (1); Miltex, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EMS
- Run a recall and safety report across every EMS manufacturer
- Watch product code EMS 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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