# K801639: Permite Dental Amalgam Alloy

- Pathway: 510(k) (Traditional)
- Applicant: Southern Dental Industries, Inc.
- Decided: Aug 27, 1980 after 41 days
- Product code: EJJ (Alloy, 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- 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 (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K801639
Methodology: https://510kreport.com/methodology