FDA 510(k) Application Details - K161219

Device Classification Name Powder, Porcelain

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510(K) Number K161219
Device Name Powder, Porcelain
Applicant Maxx Digm, Inc.
3265 Kifer Road
Santa Clara, CA 95051 US
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Contact Keith Jew
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 04/29/2016
Decision Date 01/26/2017
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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