Celebrace Software— 510(k) K253343

Substantially Equivalent

Celebrace

FDA 510(k) clearance K253343 for Celebrace Software, Substantially Equivalent on 2025-12-29. Applicant: Celebrace. Device class: 2.

Clearance details

Applicant: Celebrace
Product code: Code PNN
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2025-09-30
Decision date: 2025-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colleyville, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PNN

K260419 — LingOral Dental Design System2026-05-08
K253565 — SureSmile Software2026-03-04
K252507 — SmileInspector2026-01-07
K250198 — Laon Ortho2025-04-23
K241153 — Progressive Orthodontics App2024-10-11

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