510(k) K223182

Device

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

Applicant

Worldwork S.R.L

510(k) number

K223182

Product code

OIV

Decision

Substantially Equivalent (SESE)

Decision date

2023-05-01

Date received

2022-10-11

Regulation

872.3070

Classification name

Dental Amalgam

Medical specialty

Dental

Review panel

Dental

Device class

2

Clearance type

Abbreviated

Statement or summary

Summary

Third party reviewed

No