# K061580: Eclipse Wax Remover

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International
- Decided: Jul 28, 2006 after 51 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 K011560 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011560: Trubyte Denture Base Resin System, Dentsply Intl. (2001)

## Indications for use
The ECLIPSE® WAX REMOVER is used as an accessory to Eclipse® Prosthetic Resin System to remove wax and aid in adhesion to other acrylic resins in (1) the fabrication of dentures, appliances, and prostheses; (2) repair of dentures, appliances, and prostheses; and (3) relining of denture surfaces.

Source page: https://510kreport.com/device/K061580
Methodology: https://510kreport.com/methodology