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FDA 510(k) Application Details - K200191
Device Classification Name
More FDA Info for this Device
510(K) Number
K200191
Device Name
Sirona Dental CAD/CAM System with InLab Software
Applicant
Dentsply Sirona
221 West Philadelphia St., Suite 60W
York, PA 17401 US
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Contact
Karl J. Nittinger
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PNP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/27/2020
Decision Date
08/19/2020
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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