510(k) K253565

SureSmile Software by Dentsply Sirona, Inc. — Product Code PNN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 4, 2026
Date Received: November 17, 2025
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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Other clearances for product code PNN

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