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510(k) K232564

Align Studio by Laon Medi, Inc. — Product Code PNN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2024
Date Received
August 24, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthodontic Software
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

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.

Other clearances by Laon Medi, Inc.

  • K250198 — Laon Ortho (April 23, 2025)

Other clearances for product code PNN

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  • K252507 — SmileInspector (January 7, 2026)
  • K253343 — Celebrace Software (December 29, 2025)
  • K250198 — Laon Ortho (April 23, 2025)
  • K241153 — Progressive Orthodontics App (October 11, 2024)
  • K233625 — RAYDENT SW (May 16, 2024)
  • K233616 — Clevaligner Software (V1.0.0) (January 11, 2024)
  • K232549 — NemoCast (November 21, 2023)
  • K232429 — Titan Dental Design (October 13, 2023)
  • K223518 — iOrtho (June 13, 2023)