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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K151965
Device Name Dentti System
Applicant
Martz, Inc.
8421 Blue Heron Dr.
Bakersfield,  CA  93312
Applicant Contact Andrew Martz
Correspondent
Texel Fortis, LLC
150 Levinberg Ln.
Wayne,  NJ  07470
Correspondent Contact Mason Diamond
Regulation Number872.5470
Classification Product Code
NXC  
Date Received07/16/2015
Decision Date 03/11/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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