FDA 510(k) Application Details - K962277

Device Classification Name Agent, Tooth Bonding, Resin

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510(K) Number K962277
Device Name Agent, Tooth Bonding, Resin
Applicant DENT ZAR, INC.
19643 TRULL BROOK DR.
TARZANA, CA 91356 US
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Contact EUGENE ZAROTSKY
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Regulation Number 872.3200

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Classification Product Code KLE
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Date Received 06/13/1996
Decision Date 07/03/1996
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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