The following data is part of a premarket notification filed by Digital Orthodontic Care with the FDA for Surecure Orthodontic Aligner System.
| Device ID | K182329 |
| 510k Number | K182329 |
| Device Name: | SureCure Orthodontic Aligner System |
| Classification | Aligner, Sequential |
| Applicant | Digital Orthodontic Care 348 Bronte Street, Unit 16 Milton, CA L925b6 |
| Contact | Jeff Sheppard |
| Correspondent | Patsy J. Trisler Trisler Consulting 5600 Wisconsin Avenue, #509 Chevy Chase, MD 20815 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-28 |
| Decision Date | 2018-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D918SCA2 | K182329 | 000 |
| 00850004223222 | K182329 | 000 |
| 08500042230004 | K182329 | 000 |