Cleared Traditional

K252507 - SmileInspector (FDA 510(k) Clearance)

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

K252507 · Amv Consulting, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
152d
Days
Class 2
Risk

K252507 is an FDA 510(k) clearance for the SmileInspector. Classified as Orthodontic Software (product code PNN), Class II - Special Controls.

Submitted by Amv Consulting, LLC (Bothell, US). The FDA issued a Cleared decision on January 7, 2026 after a review of 152 days - an extended review cycle.

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 Amv Consulting, LLC devices

Submission Details

510(k) Number K252507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2025
Decision Date January 07, 2026
Days to Decision 152 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
25d slower than avg
Panel avg: 127d · This submission: 152d
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 Consultant

Devicemc, LLC
Na Zhang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PNN Orthodontic Software

All 32
Devices cleared under the same product code (PNN) and FDA review panel - the closest regulatory comparables to K252507.
SureSmile Software
K253565 · Dentsply Sirona, Inc. · Mar 2026
Celebrace Software
K253343 · Celebrace · Dec 2025
Laon Ortho
K250198 · Laon Medi, Inc. · Apr 2025
Progressive Orthodontics App
K241153 · Progressive Aligners, Inc. · Oct 2024
RAYDENT SW
K233625 · Ray Co., Ltd. · May 2024
Align Studio
K232564 · Laon Medi, Inc. · Mar 2024