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510(k) K231181

bright CT by Dentium Co., Ltd (Ict Branch) — Product Code OAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2023
Date Received
April 26, 2023
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.

Other clearances by Dentium Co., Ltd (Ict Branch)

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