FDA 510(k) Application Details - K003509

Device Classification Name Alloy, Metal, Base

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510(K) Number K003509
Device Name Alloy, Metal, Base
Applicant AMERICAN DENT-ALL, INC.
5140 SAN FERNANDO RD.
GLENDALE, CA 91204 US
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Contact VACHAKAN H KHOIE
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Regulation Number 872.3710

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Classification Product Code EJH
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Date Received 11/14/2000
Decision Date 01/02/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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