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Align Studio

by Laon Medi, Inc.

510(k) K232564

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK232564 Date12 Mar 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
PNN
Device Class
Class II
Regulation
21 CFR Part 872.5470
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Align Studio is an orthodontic software designed for dental clear aligner treatment planning and review. The platform utilizes deep-learning technology to reduce simple repetitive work and time-consuming processes in orthodontic workflows.

Align Studio is a Class 2 dental device with product code PNN, manufactured by Laon Medi, Inc. It is supplied as software and received FDA 510(k) clearance through the Traditional pathway on March 12, 2024, with K232564. The device is not indicated for single-use or reuse and does not specify MRI safety, sterility, or storage requirements.

Other devices from Laon Medi, Inc.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is Align Studio used for in dental practices?

    Align Studio is an orthodontic software designed for dental clear aligner treatment planning and review. It utilizes deep-learning technology to reduce simple repetitive work and time-consuming processes in orthodontic workflows.

  • How is Align Studio supplied and what is its regulatory status?

    Align Studio is supplied as software and received FDA 510(k) clearance through the Traditional pathway on March 12, 2024, with K232564. It is a Class 2 dental device with product code PNN, manufactured by Laon Medi, Inc.

  • Is Align Studio designed for single-use or reuse?

    The device is not indicated for single-use or reuse. As a software platform, it is designed for repeated use in dental practices for orthodontic treatment planning and review purposes.

  • What are the specifications of Align Studio?

    Align Studio is a Class 2 dental device with product code PNN. It was found to be substantially equivalent and received clearance through the Traditional pathway. The device is manufactured by Laon Medi, Inc. and is not specified for MRI safety, sterility, or storage requirements.