The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Clarity Aligners.
| Device ID | K192119 |
| 510k Number | K192119 |
| Device Name: | 3M Clarity Aligners |
| Classification | Aligner, Sequential |
| Applicant | 3M Company 2510 Conway Avenue St. Paul, MN 55144 |
| Contact | Yanine Garcia-quezada |
| 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 | 2019-08-06 |
| Decision Date | 2019-09-05 |
| Summary: | summary |