K201940 is an FDA 510(k) clearance for the Braces on Demand Bracket. This device is classified as a Bracket, Plastic, Orthodontic (Class II - Special Controls, product code DYW).
Submitted by Braces on Demand, Inc. (Hicksville, US). The FDA issued a Cleared decision on December 3, 2020, 143 days after receiving the submission on July 13, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470.
| 510(k) Number | K201940 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2020 |
| Decision Date | December 03, 2020 |
| Days to Decision | 143 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 |