FDA product code EME: Punch, Biopsy, Surgical
EME is the FDA product code for punch, biopsy, surgical. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel. FDA has cleared 3 510(k) submissions under EME, from 3 different applicants. The average 510(k) review took 160 days (median 163). FDA has posted 1 recall for EME devices.
Classification
| Field | Value |
|---|---|
| Device name | Punch, Biopsy, 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 EME clearance
Top EME applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Byron Medical | 1 | 1994-01-07 |
| Pulpdent Corp. | 1 | 1991-10-09 |
| Buckman Co., Inc. | 1 | 1989-03-06 |
Most recent EME clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933670 | Byron Medical | BIOPSY PUNCH, SURGICAL | 1994-01-07 | 163 |
| K911285 | Pulpdent Corp. | PULPDENT POLYAMIDE DENTIN LINER | 1991-10-09 | 204 |
| K884740 | Buckman Co., Inc. | EURO-MED LIGHT TOUCH BIOPSY PUNCH | 1989-03-06 | 112 |
Recalls for EME devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-03-30.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code EME?
EME is the FDA product code for punch, biopsy, surgical. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EME?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EME?
Across 3 cleared submissions the average was 160 days from receipt to decision (median 163).
Which companies have the most EME clearances?
Byron Medical (1); Pulpdent Corp. (1); Buckman Co., Inc. (1).
Have EME devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-03-30.
Next steps
- Run an FDA pathway report with predicate devices for product code EME
- Run a recall and safety report across every EME manufacturer
- Watch product code EME 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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