K080749 is an FDA 510(k) clearance for the RADIANCE. This device is classified as a Bracket, Ceramic, Orthodontic (Class II - Special Controls, product code NJM).
Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on August 4, 2008, 140 days after receiving the submission on March 17, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470. An Orthodontic Ceramic Bracket Is A Device Composed Of Ceramic, Which Is Intended To Be Bonded To A Tooth, Upon Which An Orthodontic Wire Is Used To Move The Tooth To A New Position..
| 510(k) Number | K080749 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2008 |
| Decision Date | August 04, 2008 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | NJM — Bracket, Ceramic, Orthodontic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5470 |
| Definition | An Orthodontic Ceramic Bracket Is A Device Composed Of Ceramic, Which Is Intended To Be Bonded To A Tooth, Upon Which An Orthodontic Wire Is Used To Move The Tooth To A New Position. |