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510(k) K252353

myray ProXIma X6 by Cefla S.C. — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2026
Date Received
July 29, 2025
Clearance Type
Traditional
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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