The following data is part of a premarket notification filed by Ohlendorf Appliance Laboratory with the FDA for Ohlendorf Clear Aligner.
| Device ID | K210540 |
| 510k Number | K210540 |
| Device Name: | Ohlendorf Clear Aligner |
| Classification | Aligner, Sequential |
| Applicant | Ohlendorf Appliance Laboratory 2840 Clark Avenue St. Louis, MO 63103 |
| Contact | Kevin Ohlendorf |
| Correspondent | Patsy J. Trisler Trisler Consulting 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 | 2021-02-24 |
| Decision Date | 2021-05-19 |