Clearance Summary
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 received FDA 510(k) clearance under submission number K223182, sponsored by Worldwork S.R.L. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-05-01.
- Submission: K223182
- Applicant / Sponsor: Worldwork S.R.L
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3070
- Decision date: 2023-05-01
Classification & Regulation
This clearance is catalogued under FDA product code OIV and 21 CFR 872.3070, within the Dental review panel as a Class II device.