K032625 is an FDA 510(k) clearance for the ORTHODONTIC COMPOSITE BRACKET SYSTEM. This device is classified as a Bracket, Plastic, Orthodontic (Class II - Special Controls, product code DYW).
Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 26, 2004, 184 days after receiving the submission on August 26, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470.
| 510(k) Number | K032625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2003 |
| Decision Date | February 26, 2004 |
| Days to Decision | 184 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 |