K843742 is an FDA 510(k) clearance for the UNITEK CONVERTIBLE CAP REMOVER TOOL. 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 9, 1984, 45 days after receiving the submission on September 25, 1984.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K843742 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1984 |
| Decision Date | November 09, 1984 |
| Days to Decision | 45 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 |