Cleared Traditional

K253565 - SureSmile Software (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253565 · Dentsply Sirona, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Mar 2026
Decision
107d
Days
Class 2
Risk

K253565 is an FDA 510(k) clearance for the SureSmile Software. Classified as Orthodontic Software (product code PNN), Class II - Special Controls.

Submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on March 4, 2026 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentsply Sirona, Inc. devices

Submission Details

510(k) Number K253565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 127d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PNN Orthodontic Software
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - PNN Orthodontic Software

All 32
Devices cleared under the same product code (PNN) and FDA review panel - the closest regulatory comparables to K253565.
SmileInspector
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Progressive Orthodontics App
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RAYDENT SW
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Align Studio
K232564 · Laon Medi, Inc. · Mar 2024