Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy— 510(k) K223182

Name: FDA 510(k) clearance K223182
Creator: U.S. Food and Drug Administration
Published: 2023-05-01

Substantially Equivalent

Worldwork S.R.L

FDA 510(k) clearance K223182 for Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy, Substantially Equivalent on 2023-05-01. Applicant: Worldwork S.R.L. Device class: 2.

Clearance details

Applicant: Worldwork S.R.L
Product code: Code OIV
Device class: Class 2
Regulation: 21 CFR 872.3070
Advisory panel: Dental
Date received: 2022-10-11
Decision date: 2023-05-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Montebello, IT

Download summary PDF View on FDA.gov ↗

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