# K901789: Paladon (R) 65

- Pathway: 510(k) (Traditional)
- Applicant: Kulzer, Inc.
- Decided: Jun 22, 1990 after 64 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.
84 later devices descend from it; 3 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K991220: Vitron H (1999), 60 descendants of its own
- K992645: Sinfony (1999), 59 descendants of its own
- K071131: UNO (2007), 35 descendants of its own
- K110302: Adhesive Exl-759 (2011), 34 descendants of its own
- K081884: Major.Base 20 (2008), 21 descendants of its own

Source page: https://510kreport.com/device/K901789
Methodology: https://510kreport.com/methodology