The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc with the FDA for Ultra Sep.
| Device ID | K210945 |
| 510k Number | K210945 |
| Device Name: | Ultra SEP |
| Classification | Agent, Tooth Bonding, 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-30 |
| Decision Date | 2021-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D798USEPUSAM0 | K210945 | 000 |
| D798USEP0 | K210945 | 000 |
| D798USEP2ML0 | K210945 | 000 |