FDA 510(k) Application Details - K960028

Device Classification Name Unit, X-Ray, Intraoral

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510(K) Number K960028
Device Name Unit, X-Ray, Intraoral
Applicant DENTSPLY INTL.
570 WEST COLLEGE AVE.
YORK, PA 17405-0872 US
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Contact ALAN P KREMA
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Regulation Number 872.1810

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Classification Product Code EAP
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Date Received 01/02/1996
Decision Date 03/01/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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