FDA product code EGN: Scissors, Surgical Tissue, Dental
EGN is the FDA product code for scissors, surgical tissue, dental. 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 EGN, from 3 different applicants. The average 510(k) review took 36 days (median 25).
Classification
| Field | Value |
|---|---|
| Device name | Scissors, Surgical Tissue, Dental |
| 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 EGN clearance
Top EGN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Conphar, Inc. | 5 | 1982-05-28 |
| Gendex Corp. | 1 | 1993-07-26 |
| Artiberia | 1 | 1985-07-02 |
Most recent EGN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932675 | Gendex Corp. | GXP DENTAL X-RAY PROCESSOR | 1993-07-26 | 54 |
| K851720 | Artiberia | 1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS | 1985-07-02 | 68 |
| K821275 | Conphar, Inc. | MAYO SCISSOR STRAIGHT 5 1/2 | 1982-05-28 | 25 |
| K821294 | Conphar, Inc. | TONSIL SCISSORS STRAIGHT 5 1/2 | 1982-05-28 | 24 |
| K821276 | Conphar, Inc. | MAYO SCISSOR CURYED 5 1/2 | 1982-05-28 | 25 |
Recalls for EGN devices
openFDA lists no recalls for product code EGN.
Frequently asked questions
What is FDA product code EGN?
EGN is the FDA product code for scissors, surgical tissue, dental. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EGN?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EGN?
Across 7 cleared submissions the average was 36 days from receipt to decision (median 25).
Which companies have the most EGN clearances?
Conphar, Inc. (5); Gendex Corp. (1); Artiberia (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EGN
- Run a recall and safety report across every EGN manufacturer
- Watch product code EGN 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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