FDA 510(k) Application Details - K992519

Device Classification Name Sealant, Pit And Fissure, And Conditioner

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510(K) Number K992519
Device Name Sealant, Pit And Fissure, And Conditioner
Applicant DENTSPLY INTL.
570 WEST COLLEGE AVE.
YORK, PA 17405-0872 US
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Contact P. JEFFERY LEHN
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Regulation Number 872.3765

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Classification Product Code EBC
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Date Received 07/28/1999
Decision Date 10/22/1999
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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