FDA 510(k) Application Details - K151965

Device Classification Name Aligner, Sequential

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510(K) Number K151965
Device Name Aligner, Sequential
Applicant Martz, Inc
8421 Blue Heron Drive
Bakersfield, CA 93312 US
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Contact Andrew Martz
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Regulation Number 872.5470

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Classification Product Code NXC
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Date Received 07/16/2015
Decision Date 03/11/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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