# K111832: Paladon Ultra Powder (Pink), Paladon Ultra Liquid

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, LLC
- Decided: Sep 29, 2011 after 93 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 K043504 (2005). 1 ancestor in all.
9 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)
- K043504: Palaimpact, Heraeus Kulzer, Inc. (2005) Summary page 1.

## Most influential descendants
- 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
- K253236: G-Block (2025), 0 descendants of its own

## Indications for use
Paladon ultra is a heat curing high impact denture base resin designed for injection procedure and press and pack technique for: *maxillary and mandibular prostheses *implant over-denture

Source page: https://510kreport.com/device/K111832
Methodology: https://510kreport.com/methodology