K955242 is an FDA 510(k) clearance for the TITANIUM BIRD BEAK PLIER. This device is classified as a Plier, Orthodontic (Class I - General Controls, product code JEX).
Submitted by Sybron Dental Specialties, Inc. (Glendora, US). The FDA issued a Cleared decision on December 1, 1995, 16 days after receiving the submission on November 15, 1995.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K955242 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 1995 |
| Decision Date | December 01, 1995 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JEX — Plier, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |