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510(k) K221921

DTX Studio Clinic 3.0 by Nobel Biocare AB — Product Code MYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2023
Date Received
July 1, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Medical Image
Device Class
Class II
Regulation Number
892.2070
Review Panel
RA
Submission Type

For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers

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