FDA 510(k) Application Details - K992838

Device Classification Name Agent, Tooth Bonding, Resin

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510(K) Number K992838
Device Name Agent, Tooth Bonding, Resin
Applicant BIOMAT SCIENCES, INC.
5612 GLENWOOD RD.
BETHESDA, MD 20817 US
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Contact IVAN STANGEL
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Regulation Number 872.3200

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Classification Product Code KLE
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Date Received 08/23/1999
Decision Date 11/15/1999
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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