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510(k) K233395

Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) by Alliage S/A Industrias Médico Odontológica — Product Code EHD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2024
Date Received
October 3, 2023
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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