# K111668: Cavios Cavity Liner

- Pathway: 510(k) (Traditional)
- Applicant: Neodental Chemical Products Co., Ltd.
- Decided: Aug 19, 2011 after 66 days
- Product code: EJK (Liner, Cavity, Calcium Hydroxide)
- Device class: 2
- Regulation: 21 CFR 872.3250
- 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 K970113 (1997). 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)
- K970113: Ultra-Blend Plus, Ultradent Products, Inc. (1997) Summary page 1.

## Indications for use
Cavios® Cavity Liner is to be applied to the interior of a prepared cavity prior to the insertion of restorative materials. Cavios®9 Cavity Liner is indicated for use in the general dental population.

Source page: https://510kreport.com/device/K111668
Methodology: https://510kreport.com/methodology