FDA 510(k) Application Details - K050903

Device Classification Name Powder, Porcelain

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510(K) Number K050903
Device Name Powder, Porcelain
Applicant WIELAND DENTAL + TECHNIK GMBH & CO. KG
SCHWENNINGER STRASSE 13
PFORZHEIM 75179 DE
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Contact GERHARD POLZER
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Regulation Number 872.6660

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Classification Product Code EIH
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Date Received 04/11/2005
Decision Date 06/23/2005
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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