FDA product code EFL: Forceps, Dressing, Dental
EFL is the FDA product code for forceps, dressing, dental. 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 EFL, from 3 different applicants. The average 510(k) review took 20 days (median 24).
Classification
| Field | Value |
|---|---|
| Device name | Forceps, Dressing, 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 EFL clearance
Top EFL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Conphar, Inc. | 3 | 1982-05-28 |
| Kinetic Medical Products | 1 | 1989-01-27 |
| Pacific Dental Corp. | 1 | 1982-07-06 |
Most recent EFL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890243 | Kinetic Medical Products | DRESSING FORCEPS | 1989-01-27 | 9 |
| K821778 | Pacific Dental Corp. | BEACH DRESSING PLIER | 1982-07-06 | 19 |
| K821285 | Conphar, Inc. | SPLINTER FORCEPS 4 1/2 | 1982-05-28 | 24 |
| K821284 | Conphar, Inc. | ADSON FORCEPS 4 3/4 | 1982-05-28 | 24 |
| K821282 | Conphar, Inc. | THUMB DRESSING FORCEPS 5 | 1982-05-28 | 25 |
Recalls for EFL devices
openFDA lists no recalls for product code EFL.
Frequently asked questions
What is FDA product code EFL?
EFL is the FDA product code for forceps, dressing, dental. It is a Class I device, regulated under 21 CFR 872.4565 and reviewed by the Dental panel.
What device class is EFL?
Class I, regulation 21 CFR 872.4565. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EFL?
Across 5 cleared submissions the average was 20 days from receipt to decision (median 24).
Which companies have the most EFL clearances?
Conphar, Inc. (3); Kinetic Medical Products (1); Pacific Dental Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EFL
- Run a recall and safety report across every EFL manufacturer
- Watch product code EFL 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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