The following data is part of a premarket notification filed by Braces On Demand, Inc with the FDA for Braces On Demand Bracket.
| Device ID | K201940 |
| 510k Number | K201940 |
| Device Name: | Braces On Demand Bracket |
| Classification | Bracket, Plastic, Orthodontic |
| Applicant | Braces On Demand, Inc 422 South Broadway, Suite 223 Hicksville, NY 11801 |
| Contact | Colin Corey |
| Correspondent | Patsy J. Trisler Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, IN 46250 |
| Product Code | DYW |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-13 |
| Decision Date | 2020-12-03 |