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510(k) K200772

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

K200772 is an FDA 510(k) premarket notification submitted by Ulab Systems, Inc. for the device "ULab Systems uDesign Software". The FDA issued a decision of Substantially Equivalent on June 23, 2020. The device falls under product code PNN (Orthodontic Software), a Class II device regulated under 21 CFR 872.5470. Ulab Systems, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2020
Date Received
March 25, 2020
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)
  • K192596 — ULab Systems Dental Aligner Kit (February 11, 2020)
  • K171295 — ULab Systems Treatment Planning Software (January 9, 2018)

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)
  • 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)

FDA data resources