# K030318: P2 Polyether

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Apr 3, 2003 after 63 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
26 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040053: Precision VPS Impression Material (2004), 25 descendants of its own
- K062450: D-Spect Cardiac Scanner System (2006), 14 descendants of its own
- K072468: Modification to D-Spect Cardiac Scanner System (2007), 10 descendants of its own
- K110507: Cardiac Scanner and Processing System (2011), 9 descendants of its own
- K052090: Splash! Impression Material Device (2005), 7 descendants of its own

## Recalls of this device
- Nov 1, 2003 · Not classified · Z-0624-05: Packaging defects could result in improper mixing ratios and unusable impressions.
- Nov 1, 2003 · Not classified · Z-0626-05: Packaging defects could result in improper mixing ratios and unusable impressions.
- Nov 1, 2003 · Not classified · Z-0627-05: Packaging defects could result in improper mixing ratios and unusable impressions.
- Nov 1, 2003 · Not classified · Z-0625-05: Packaging defects could result in improper mixing ratios and unusable impressions.

## Indications for use
P2 Polyether Impression material is used for inlay, onlay, crown & bridge preparations, functional impressions and implant impressions.

Source page: https://510kreport.com/device/K030318
Methodology: https://510kreport.com/methodology