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510(k) K130297

SCANORA 3DX by Palodex Group OY — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2013
Date Received
February 6, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
X-Ray, Tomography, Computed, Dental
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.

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