# K134022: Base IT

- Pathway: 510(k) (Traditional)
- Applicant: Spident Co., Ltd.
- Decided: Jun 11, 2014 after 163 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 K953079 (1995). 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)
- K953079: Limelight, Pulpdent Corp. (1995) Summary page 1.

## Indications for use
Base it is a light-cured, radiopaque dental liner and base material that Contains calcium hydroxyl apatite in a urethane dimetbacrylate oligower. Base it is used to line cavity preparations before restoration.

Source page: https://510kreport.com/device/K134022
Methodology: https://510kreport.com/methodology