CEPHX- Cephalometric Analysis Software— 510(k) K231396

Name: FDA 510(k) clearance K231396
Creator: U.S. Food and Drug Administration
Published: 2024-01-31

Substantially Equivalent

Orca Dental AI , Ltd.

FDA 510(k) clearance K231396 for CEPHX- Cephalometric Analysis Software, Substantially Equivalent on 2024-01-31. Applicant: Orca Dental AI , Ltd.. Device class: 2.

Clearance details

Applicant: Orca Dental AI , Ltd.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2023-05-15
Decision date: 2024-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herzliya, IL

Download summary PDF View on FDA.gov ↗

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K252538 — CEPHX3D2026-03-05

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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