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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860012168514 | K151965 | 000 |