The following data is part of a premarket notification filed by Nusmile, Ltd. with the FDA for Mta2.3 Materials.
| Device ID | K181917 |
| 510k Number | K181917 |
| Device Name: | MTA2.3 MATERIALS |
| Classification | Resin, Root Canal Filling |
| Applicant | NuSmile, LTD. 3315 W 12th Street Houston, TX 77008 |
| Contact | Alafiz Prasla |
| Correspondent | Angie Beyer NuSmile, LTD. 3315 W 12th Street Houston, TX 77008 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-17 |
| Decision Date | 2019-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205032850 | K181917 | 000 |