Cleared Traditional

K232564 - Align Studio (FDA 510(k) Clearance)

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

K232564 · Laon Medi, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
201d
Days
Class 2
Risk

K232564 is an FDA 510(k) clearance for the Align Studio. Classified as Orthodontic Software (product code PNN), Class II - Special Controls.

Submitted by Laon Medi, Inc. (Seongnam-Si, KR). The FDA issued a Cleared decision on March 12, 2024 after a review of 201 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 Laon Medi, Inc. devices

Submission Details

510(k) Number K232564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2023
Decision Date March 12, 2024
Days to Decision 201 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
74d slower than avg
Panel avg: 127d · This submission: 201d
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 K232564.
SureSmile Software
K253565 · Dentsply Sirona, Inc. · Mar 2026
SmileInspector
K252507 · Amv Consulting, LLC · Jan 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