The following data is part of a premarket notification filed by Martz, Inc with the FDA for Dentti System.
Device ID | K151965 |
510k Number | K151965 |
Device Name: | Dentti System |
Classification | Aligner, Sequential |
Applicant | Martz, Inc 8421 Blue Heron Drive Bakersfield, CA 93312 |
Contact | Andrew Martz |
Correspondent | Mason Diamond TEXEL FORTIS, LLC 150 LEVINBERG LANE Wayne, NJ 07470 |
Product Code | NXC |
CFR Regulation Number | 872.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-16 |
Decision Date | 2016-03-11 |