K932920 is an FDA 510(k) clearance for the GLENROE PLASTIC BRACKET. This device is classified as a Bracket, Plastic, Orthodontic (Class II - Special Controls, product code DYW).
Submitted by Glenroe Technologies (Bradenton, US). The FDA issued a Cleared decision on August 24, 1993, 70 days after receiving the submission on June 15, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470.
| 510(k) Number | K932920 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1993 |
| Decision Date | August 24, 1993 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | DYW — Bracket, Plastic, Orthodontic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5470 |