ULab Systems uDesign Software— 510(k) K200772

Name: FDA 510(k) clearance K200772
Creator: U.S. Food and Drug Administration
Published: 2020-06-23

Substantially Equivalent

Ulab Systems, Inc.

FDA 510(k) clearance K200772 for ULab Systems uDesign Software, Substantially Equivalent on 2020-06-23. Applicant: Ulab Systems, Inc.. Device class: 2.

Clearance details

Applicant: Ulab Systems, Inc.
Product code: Code PNN
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2020-03-25
Decision date: 2020-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Mateo, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PNN

view all

K260419 — LingOral Dental Design System2026-05-08
K253565 — SureSmile Software2026-03-04
K252507 — SmileInspector2026-01-07
K253343 — Celebrace Software2025-12-29
K250198 — Laon Ortho2025-04-23

More clearances from Ulab Systems, Inc.

view all

K211510 — uLab Systems Dental Aligner Kit2022-02-24
K192596 — ULab Systems Dental Aligner Kit2020-02-11
K171295 — ULab Systems Treatment Planning Software2018-01-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.