FDA 510(k) Application Details - K082137

Device Classification Name Powder, Porcelain

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510(K) Number K082137
Device Name Powder, Porcelain
Applicant DENTAL MILLING LABORATORY SUPPLIES (DLMS)
14201 N. 87TH ST., SUITE A-105
SCOTTSDALE, AZ 85260 US
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Contact SCOTT ATKIN
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 07/29/2008
Decision Date 02/10/2009
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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