K925012 is an FDA 510(k) clearance for the PLASTIC CHAIN. 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 September 13, 1993, 346 days after receiving the submission on October 2, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K925012 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 1992 |
| Decision Date | September 13, 1993 |
| Days to Decision | 346 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 |