K925088 is an FDA 510(k) clearance for the EXPANSION SCREWS. This device is classified as a Retainer, Screw Expansion, Orthodontic (Class I - General Controls, product code DYJ).
Submitted by Forestadent (Germany, DE). The FDA issued a Cleared decision on May 22, 1993, 227 days after receiving the submission on October 7, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.
| 510(k) Number | K925088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 1992 |
| Decision Date | May 22, 1993 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | DYJ — Retainer, Screw Expansion, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5410 |