The following data is part of a premarket notification filed by K Line Europe Gmbh with the FDA for K Clear.
| Device ID | K220726 |
| 510k Number | K220726 |
| Device Name: | K Clear |
| Classification | Aligner, Sequential |
| Applicant | K Line Europe GmbH Niederrheinstraße 16 Dusseldorf, DE 40474 |
| Contact | Sherif Kandil |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-03-14 |
| Decision Date | 2022-03-16 |