FDA product code EMN: Scaler, Periodontic
EMN is the FDA product code for scaler, periodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 5 510(k) submissions under EMN, from 5 different applicants. The average 510(k) review took 97 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Scaler, 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 EMN clearance
Top EMN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kevin Vu, Dds | 1 | 2007-03-29 |
| Minnesota Prophy Power, Inc. | 1 | 1994-01-26 |
| Artiberia | 1 | 1985-07-02 |
| Pacific Dental Corp. | 1 | 1982-07-06 |
| Premier Dental Products Co. | 1 | 1978-06-30 |
Most recent EMN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070127 | Kevin Vu, Dds | PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 | 2007-03-29 | 72 |
| K931330 | Minnesota Prophy Power, Inc. | DENTAL INSTRUMENTS SCALER | 1994-01-26 | 316 |
| K851721 | Artiberia | 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS | 1985-07-02 | 68 |
| K821786 | Pacific Dental Corp. | BEACH SCALERS | 1982-07-06 | 19 |
| K781035 | Premier Dental Products Co. | PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX | 1978-06-30 | 11 |
Recalls for EMN devices
openFDA lists no recalls for product code EMN.
Frequently asked questions
What is FDA product code EMN?
EMN is the FDA product code for scaler, periodontic. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EMN?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EMN?
Across 5 cleared submissions the average was 97 days from receipt to decision (median 68).
Which companies have the most EMN clearances?
Kevin Vu, Dds (1); Minnesota Prophy Power, Inc. (1); Artiberia (1); Pacific Dental Corp. (1); Premier Dental Products Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EMN
- Run a recall and safety report across every EMN manufacturer
- Watch product code EMN 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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