K923261 is an FDA 510(k) clearance for the ORTHODONTIC METAL BRACKET. This device is classified as a Bracket, Metal, Orthodontic (Class I - General Controls, product code EJF).
Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on December 3, 1992, 154 days after receiving the submission on July 2, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K923261 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 1992 |
| Decision Date | December 03, 1992 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EJF — Bracket, Metal, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5410 |