K160720 is an FDA 510(k) clearance for the Carriere Motion Clear Class II. This device is classified as a Bracket, Plastic, Orthodontic (Class II - Special Controls, product code DYW).
Submitted by Ortho Organizers, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 28, 2016, 257 days after receiving the submission on March 16, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470.
| 510(k) Number | K160720 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2016 |
| Decision Date | November 28, 2016 |
| Days to Decision | 257 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DYW - Bracket, Plastic, Orthodontic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5470 |