# K080514: Pecd-01 and Pecd Quick-01

- Pathway: 510(k) (Special)
- Applicant: 3M Espe AG Dental Products
- Decided: Mar 26, 2008 after 30 days
- 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: 4 generations back to K954192 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994192: Impregum Penta M Monosoft, Espe Dental AG (2000) Summary page 1.
- K032001: Poly Q (Garant L, Penta M, Penta H), 3M Espe AG Dental Products (2003) Summary page 1.
- K952693: Ramitec Penta, Espe GmbH & Co. Kg. (1995) Summary page 1.

## Indications for use
Impressions for inlay, onlay, crown, and bridge restorations Functional impressions Fixation impressions Implant irripressions

Source page: https://510kreport.com/device/K080514
Methodology: https://510kreport.com/methodology