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510(k) K200271

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2021
Date Received
February 4, 2020
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.

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

  • K231181 — bright CT (December 14, 2023)
  • K200270 — rainbow MCT (April 16, 2021)
  • K201247 — Intraoral Sensor (June 10, 2020)

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