# K110037: Palaxpress Ultra Powder (Pink); Palaxpress Ultra Liquid

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, LLC
- Decided: Apr 29, 2011 after 113 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
Longest line of descent: 1 generation back to K902115 (1990). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902115: Palapress (R) Vario Resin, Kulzer, Inc. (1990) Summary page 1.

## Most influential descendants
- K130680: Acrytone, Rezen NF, and Iso Fast Denture Resins (2013), 1 descendant of its own
- K170375: Nobilplast Denture Resin (2017), 0 descendants of its own

## Indications for use
Universal high fracture resistant denture base material. Used with injection or pouring techniques for fixed or removable dentures. Injection procedure: - Full maxillary and mandibular prostheses - Implant over denture Pouring procedure: - Implant over denture - Partial dentures. Multiple or single saddles - Marginal contour and reshaping - Repairs and additions - Relines - Dental splints

Source page: https://510kreport.com/device/K110037
Methodology: https://510kreport.com/methodology