# K032001: Poly Q (Garant L, Penta M, Penta H)

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe AG Dental Products
- Decided: Aug 11, 2003 after 45 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: 3 generations back to K954192 (1995). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994190: Impregum Garant L Duosoft, Espe Dental AG (2000) Summary page 2.
- K994192: Impregum Penta M Monosoft, Espe Dental AG (2000) Summary page 2.
- K994193: Impregum Penta Duosoft, Espe Dental AG (2000) Summary page 2.

## Most influential descendants
- K173318: Rapid HB, Rapid LB, Rapid MB (2017), 0 descendants of its own
- K080514: Pecd-01 and Pecd Quick-01 (2008), 0 descendants of its own

## Indications for use
Poly Q Garant L: Wash material for dual phase impression techniques. Poly Q Penta M: Impression material for monophase technique. Poly Q Penta H: Tray material for dual phase impression techniques.

Source page: https://510kreport.com/device/K032001
Methodology: https://510kreport.com/methodology