K923432 is an FDA 510(k) clearance for the GERMAN MINI DYNALOCK. This device is classified as a Bracket, Metal, Orthodontic (Class I - General Controls, product code EJF).
Submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on October 30, 1992, 109 days after receiving the submission on July 13, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K923432 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1992 |
| Decision Date | October 30, 1992 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EJF — Bracket, Metal, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5410 |