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FDA 510(k) Application Details - K162888
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K162888
Device Name
Powder, Porcelain
Applicant
Dentsply Sirona
221 West Philadelphia Street
Suite 60
York, PA 17404 US
Other 510(k) Applications for this Company
Contact
Karl Nittinger
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/17/2016
Decision Date
02/24/2017
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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