# K220257: Permadyne

- Pathway: 510(k) (Traditional)
- Applicant: 3M Deutschland GmbH
- Decided: Feb 1, 2022 after 1 day
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- 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 K800031 (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)
- K800031: Permadyne Polyether Rubber Impression, Espe Dental Products (1980) Summary page 4.

## Indications for use
* Impression of inlay, onlay, crown, bridge, and veneer preparations * Functional impressions

Source page: https://510kreport.com/device/K220257
Methodology: https://510kreport.com/methodology