K854088 is an FDA 510(k) clearance for the UNITEK LIFT-OFF DEBRACKETING INSTRUMENT. This device is classified as a Plier, Orthodontic (Class I - General Controls, product code JEX).
Submitted by Unitex Corp. (Monrovia, US). The FDA issued a Cleared decision on November 26, 1985, 50 days after receiving the submission on October 7, 1985.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K854088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1985 |
| Decision Date | November 26, 1985 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | JEX — Plier, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |