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510(k) K210820

EAGLE EDGE AXR90 and AXR120 by Alliage S/A Industrias Medico Odontológica — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2021
Date Received
March 19, 2021
Clearance Type
Abbreviated
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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