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FDA 510(k) Application Details - K230095
Device Classification Name
System,X-Ray,Extraoral Source,Digital
More FDA Info for this Device
510(K) Number
K230095
Device Name
System,X-Ray,Extraoral Source,Digital
Applicant
Durr Dental SE
Hopfigheimer Str. 17
Bietigheim-Bissingen 74321 DE
Other 510(k) Applications for this Company
Contact
Oliver Lange
Other 510(k) Applications for this Contact
Regulation Number
872.1800
More FDA Info for this Regulation Number
Classification Product Code
MUH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/12/2023
Decision Date
02/06/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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