The following data is part of a premarket notification filed by Dentcare Dental Lab Pvt Ltd. with the FDA for Dentcare Aligners.
| Device ID | K222918 |
| 510k Number | K222918 |
| Device Name: | DentCare Aligners |
| Classification | Aligner, Sequential |
| Applicant | DentCare Dental Lab Pvt Ltd. NAS Road, 130 Jn. Muvattupuzha Ernakulam, IN 686661 |
| Contact | Abin Johns Raju |
| Correspondent | Manoj Zacharias Liberty Management Group Ltd. 75 Executive Drive, Suite 114 Aurora, IL 60504 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-26 |
| Decision Date | 2022-11-25 |