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 |