510(k) K223182
K223182 is an FDA 510(k) premarket notification submitted by Worldwork S.R.L for the 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". The FDA issued a decision of Substantially Equivalent on May 1, 2023. The device falls under product code OIV (Dental Amalgam), a Class II device regulated under 21 CFR 872.3070.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 2023
- Date Received
- October 11, 2022
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dental Amalgam
- Device Class
- Class II
- Regulation Number
- 872.3070
- Review Panel
- DE
- Submission Type
Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth