FDA 510(k) Application Details - K071010

Device Classification Name Powder, Porcelain

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510(K) Number K071010
Device Name Powder, Porcelain
Applicant SCHUTZ-DENTAL GMBH
DIESELSTRASSE 5-6
ROSBACH, HESSEN D-61191 DE
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Contact MICHAEL WIERZ
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 04/09/2007
Decision Date 08/24/2007
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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