FDA product code EML: Chisel, Bone, Surgical
EML is the FDA product code for chisel, bone, surgical. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under EML, from 2 different applicants. The average 510(k) review took 32 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Chisel, Bone, 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 EML clearance
Top EML applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Artiberia | 1 | 1985-06-11 |
| Miltex, Inc. | 1 | 1982-11-24 |
Most recent EML clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K851715 | Artiberia | 830/4 TO 848/7 VARIOUS TYPES CHISELS | 1985-06-11 | 47 |
| K823320 | Miltex, Inc. | DENTAL INSTRUMENTS - BONE CHISELS | 1982-11-24 | 16 |
Recalls for EML devices
openFDA lists no recalls for product code EML.
Frequently asked questions
What is FDA product code EML?
EML is the FDA product code for chisel, bone, surgical. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EML?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EML?
Across 2 cleared submissions the average was 32 days from receipt to decision (median 32).
Which companies have the most EML clearances?
Artiberia (1); Miltex, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EML
- Run a recall and safety report across every EML manufacturer
- Watch product code EML 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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