# K043504: Palaimpact

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Jan 28, 2005 after 39 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 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
- K111832: Paladon Ultra Powder (Pink), Paladon Ultra Liquid (2011), 9 descendants of its own
- K132725: Juvora Dentqal Disc (2014), 8 descendants of its own
- K160918: JUVORA Dental Disc, Ceramill PEEK by JUVORA (2017), 3 descendants of its own
- K152113: BioHPP - breCAM.BioHPP (2016), 3 descendants of its own
- K220329: G-CAM (2022), 1 descendant of its own

## Indications for use
PalaImpact is a heat curing, high-impact denture acrylic resin for fabrication of full and partial dentures. This acrylic resin is also used for fixed and removable prosthetics devices.

Source page: https://510kreport.com/device/K043504
Methodology: https://510kreport.com/methodology