# K111666: Evadyne Temporary Crown and Bridge Resin

- Pathway: 510(k) (Traditional)
- Applicant: Neodental Chemical Products Co., Ltd.
- Decided: Sep 7, 2011 after 85 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- 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 K934978 (1993). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934978: Fermit N Light-Curing Temporary Filling Material, Ivoclar North America, Inc. (1993) Summary page 3.

## Most influential descendants
- K192158: DiaTemp (2020), 0 descendants of its own

## Indications for use
Evadyne is a light cured single-component material for the temporary restoration of crowns, bridges, or similar dental prostheses. Evadyne is intended for the general dental patient population.

Source page: https://510kreport.com/device/K111666
Methodology: https://510kreport.com/methodology