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FDA 510(k) Application Details - K000169
Device Classification Name
Agent, Polishing, Abrasive, Oral Cavity
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510(K) Number
K000169
Device Name
Agent, Polishing, Abrasive, Oral Cavity
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
872.6030
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Classification Product Code
EJR
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More FDA Info for this Product Code
Date Received
01/20/2000
Decision Date
03/24/2000
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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