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510(k) K212770

Vision by Softsmile, Inc. — Product Code PNN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2021
Date Received
August 31, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthodontic Software
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.

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