Home / 510(k) Clearances / K171295

510(k) K171295

ULab Systems Treatment Planning Software by Ulab Systems, Inc. — Product Code PNN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2018
Date Received
May 2, 2017
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 Ulab Systems, Inc.

  • K211510 — uLab Systems Dental Aligner Kit (February 24, 2022)
  • K200772 — ULab Systems uDesign Software (June 23, 2020)
  • K192596 — ULab Systems Dental Aligner Kit (February 11, 2020)

Other clearances for product code PNN

  • K253565 — SureSmile Software (March 4, 2026)
  • 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)
  • 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)