Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)— 510(k) K233395

Name: FDA 510(k) clearance K233395
Creator: U.S. Food and Drug Administration
Published: 2024-01-03

Substantially Equivalent

Alliage S/A Industrias Médico Odontológica

FDA 510(k) clearance K233395 for Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S), Substantially Equivalent on 2024-01-03. Applicant: Alliage S/A Industrias Médico Odontológica. Device class: 2.

Clearance details

Applicant: Alliage S/A Industrias Médico Odontológica
Product code: Code EHD
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2023-10-03
Decision date: 2024-01-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sao Paulo, BR

Download summary PDF View on FDA.gov ↗

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