Dentti System

Aligner, Sequential

Martz, Inc

The following data is part of a premarket notification filed by Martz, Inc with the FDA for Dentti System.

Pre-market Notification Details

Device IDK151965
510k NumberK151965
Device Name:Dentti System
ClassificationAligner, Sequential
Applicant Martz, Inc 8421 Blue Heron Drive Bakersfield,  CA  93312
ContactAndrew Martz
CorrespondentMason Diamond
TEXEL FORTIS, LLC 150 LEVINBERG LANE Wayne,  NJ  07470
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-16
Decision Date2016-03-11

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