K924295 is an FDA 510(k) clearance for the DEBRACKETING INSTRUMENT. This device is classified as a Plier, Orthodontic (Class I - General Controls, product code JEX).
Submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on November 23, 1992, 89 days after receiving the submission on August 26, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K924295 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 1992 |
| Decision Date | November 23, 1992 |
| Days to Decision | 89 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 |