# K141047: LC Calciumhydroxide Liner

- Pathway: 510(k) (Traditional)
- Applicant: S&C Polymer Silicon- Und Composite Spezialitaeten
- Decided: Apr 14, 2015 after 356 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 K924182 (1992). 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)
- K924182: Calcimol LC, Voco GmbH (1992) Summary page 4.

## Indications for use
Application to dentin as a protective barrier between restorative materials and deep vital dentin (indirect pulp capping) Lining of cavities for following filling procedures

Source page: https://510kreport.com/device/K141047
Methodology: https://510kreport.com/methodology