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510(k) K193659

iTero Element 5D by Align Technology, Inc. — Product Code NTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2020
Date Received
December 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Caries Detector, Laser Light, Transmission
Device Class
Class II
Regulation Number
872.1745
Review Panel
DE
Submission Type

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