The following data is part of a premarket notification filed by Ortho Lab Services, Llc with the FDA for Ortho Aligner System.
| Device ID | K212496 |
| 510k Number | K212496 |
| Device Name: | Ortho Aligner System |
| Classification | Aligner, Sequential |
| Applicant | Ortho Lab Services, LLC 251 Little Falls Wilmington, DE 19808 |
| Contact | Zuzana Huelsbusch |
| Correspondent | Patsy J. Trisler Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, IN 46250 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-09 |
| Decision Date | 2021-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850007728267 | K212496 | 000 |