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FDA 510(k) Application Details - K172007
Device Classification Name
Caries Detector, Laser Light, Transmission
More FDA Info for this Device
510(K) Number
K172007
Device Name
Caries Detector, Laser Light, Transmission
Applicant
Duerr Dental AG
Hopfigheimer Strasse 17
Bietigheim-Bissingen D-74321 DE
Other 510(k) Applications for this Company
Contact
Oliver Lange
Other 510(k) Applications for this Contact
Regulation Number
872.1745
More FDA Info for this Regulation Number
Classification Product Code
NTK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/03/2017
Decision Date
11/22/2017
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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