The following data is part of a premarket notification filed by Dentsply Sirona with the FDA for Mtm Clear Aligner.
| Device ID | K163155 |
| 510k Number | K163155 |
| Device Name: | MTM Clear Aligner |
| Classification | Aligner, Sequential |
| Applicant | DENTSPLY SIRONA 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17408 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY SIRONA 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17408 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-10 |
| Decision Date | 2017-02-03 |
| Summary: | summary |