Cleared Traditional

SureSmile Software

K253565 · Dentsply Sirona, Inc. · Dental

Mar 2026

Decision

107d

Days

Class 2

Risk

About This 510(k) Submission

K253565 is an FDA 510(k) clearance for the SureSmile Software, a Orthodontic Software (Class II — Special Controls, product code PNN), submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on March 4, 2026, 107 days after receiving the submission on November 17, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K253565 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 2025
Decision Date	March 04, 2026
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	PNN — Orthodontic Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.5470
Definition	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.