# K223182: 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

- Pathway: 510(k) (Abbreviated)
- Applicant: Worldwork S.R.L
- Decided: May 1, 2023 after 202 days
- Product code: OIV (Dental Amalgam)
- Device class: 2
- Regulation: 21 CFR 872.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K801639 (1980). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K801639: Permite Dental Amalgam Alloy, Southern Dental Industries, Inc. (1980) Summary page 4.

## Indications for use
Filling material as a treatment for dental caries

Source page: https://510kreport.com/device/K223182
Methodology: https://510kreport.com/methodology