The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc with the FDA for Tko Composite Bite Turbo Gel.
| Device ID | K210349 |
| 510k Number | K210349 |
| Device Name: | TKO Composite Bite Turbo Gel |
| Classification | Material, Tooth Shade, Resin |
| Applicant | Reliance Orthodontic Products, Inc 1540 W Thorndale Ave Itasca, IL 60143 |
| Contact | Christine Cook |
| Correspondent | Brian Dean Cook Device Solutions 7640 Delaine Ct Indianapolis, IN 46254 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-08 |
| Decision Date | 2021-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D798TKOP0 | K210349 | 000 |
| 00840479203515 | K210349 | 000 |
| 00840479203522 | K210349 | 000 |
| 00840479203539 | K210349 | 000 |
| 00840479200668 | K210349 | 000 |
| 00840479200675 | K210349 | 000 |
| 00840479200682 | K210349 | 000 |
| 00840479200699 | K210349 | 000 |
| D7981TKOC150 | K210349 | 000 |
| D798TKOC150 | K210349 | 000 |
| D798TKOC0 | K210349 | 000 |
| 00840479203508 | K210349 | 000 |