# K113711: Lime-Lite II

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Mar 5, 2012 after 77 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 K860633 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K860633: Fluoroseal, Dentin Sealer and Cavity Liner, Scientific Pharmaceuticals, Inc. (1986) Summary page 1.

## Indications for use
Lime-Lite II is a light-cured, calcium and fluoride releasing, radiopaque dental liner/base material that contains hydroxyapatite in a urethane dimethacrylate resin. Lime-Lite II is used to line cavity preparations before restoration.

Source page: https://510kreport.com/device/K113711
Methodology: https://510kreport.com/methodology