Home / 510(k) Clearances / K253343

510(k) K253343

Celebrace Software by Celebrace — Product Code PNN

K253343 is an FDA 510(k) premarket notification submitted by Celebrace for the device "Celebrace Software". The FDA issued a decision of Substantially Equivalent on December 29, 2025. The device falls under product code PNN (Orthodontic Software), a Class II device regulated under 21 CFR 872.5470.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2025
Date Received
September 30, 2025
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 for product code PNN

  • K260419 — LingOral Dental Design System (May 8, 2026)
  • K253565 — SureSmile Software (March 4, 2026)
  • K252507 — SmileInspector (January 7, 2026)
  • K250198 — Laon Ortho (April 23, 2025)
  • K241153 — Progressive Orthodontics App (October 11, 2024)
  • K233625 — RAYDENT SW (May 16, 2024)
  • K232564 — Align Studio (March 12, 2024)
  • K233616 — Clevaligner Software (V1.0.0) (January 11, 2024)
  • K232549 — NemoCast (November 21, 2023)
  • K232429 — Titan Dental Design (October 13, 2023)

FDA data resources