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510(k) K133231

DIGORA OPTIME by Instrumentarium Dental, Palodex Group OY — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2014
Date Received
October 21, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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