FDA 510(k) Application Details - K973782

Device Classification Name Material, Impression

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510(K) Number K973782
Device Name Material, Impression
Applicant DENTSPLY INTL.
570 WEST COLLEGE AVE.
P.O. BOX 872
YORK, PA 17405 US
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Contact P. JEFFREY LEHN
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Regulation Number 872.3660

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Classification Product Code ELW
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Date Received 10/03/1997
Decision Date 12/04/1997
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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