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FDA 510(k) Application Details - K960028
Device Classification Name
Unit, X-Ray, Intraoral
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
872.1810
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Classification Product Code
EAP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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