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510(k) K222219

R2 Studio Q/RCT820 by Megagen Implant Co., Ltd. — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2022
Date Received
July 25, 2022
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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