FDA product code EMM: Chisel, Osteotome, Surgical
EMM is the FDA product code for chisel, osteotome, surgical. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 4 510(k) submissions under EMM, from 4 different applicants. The average 510(k) review took 42 days (median 44). FDA has posted 1 recall for EMM devices.
Classification
| Field | Value |
|---|---|
| Device name | Chisel, Osteotome, Surgical |
| 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 EMM clearance
Top EMM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Steri-Oss, Inc. | 1 | 1996-11-06 |
| New England Surgical Instrument Corp. | 1 | 1987-02-12 |
| Artiberia | 1 | 1985-06-11 |
| American Safety Equipment Corp. | 1 | 1976-11-15 |
Most recent EMM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K963897 | Steri-Oss, Inc. | STERI-OSS SINUS AUGMENTATION KIT | 1996-11-06 | 40 |
| K864775 | New England Surgical Instrument Corp. | CHISEL (OSTEOTOME, GOUGE, ETC.) | 1987-02-12 | 69 |
| K851714 | Artiberia | 820/1 TO 820/51 VARIOUS TYPES BONE RONGEURS | 1985-06-11 | 47 |
| K760959 | American Safety Equipment Corp. | SURGICAL CHISEL | 1976-11-15 | 14 |
Recalls for EMM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-04-16.
Frequently asked questions
What is FDA product code EMM?
EMM is the FDA product code for chisel, osteotome, surgical. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EMM?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EMM?
Across 4 cleared submissions the average was 42 days from receipt to decision (median 44).
Which companies have the most EMM clearances?
Steri-Oss, Inc. (1); New England Surgical Instrument Corp. (1); Artiberia (1); American Safety Equipment Corp. (1).
Have EMM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-04-16.
Next steps
- Run an FDA pathway report with predicate devices for product code EMM
- Run a recall and safety report across every EMM manufacturer
- Watch product code EMM 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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