Clevaligner Software (V1.0.0)— 510(k) K233616

Name: FDA 510(k) clearance K233616
Creator: U.S. Food and Drug Administration
Published: 2024-01-11

Substantially Equivalent

Clevaligner, Ltd.

FDA 510(k) clearance K233616 for Clevaligner Software (V1.0.0), Substantially Equivalent on 2024-01-11. Applicant: Clevaligner, Ltd.. Device class: 2.

Clearance details

Applicant: Clevaligner, Ltd.
Product code: Code PNN
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2023-11-13
Decision date: 2024-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jerusalem, IL

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

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