# K230270: 3M™ VitCal Liner/Base

- Pathway: 510(k) (Traditional)
- Applicant: 3M Espe Dental Products
- Decided: Feb 6, 2023 after 6 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: 2 generations back to K922721 (1992). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063237: Theracal LC, Bisco, Inc. (2006) Summary page 4.
- K011200: Gilb, Model 8010, 3M Company (2001) Summary page 4.

## Most influential descendants
- K261728: One-Fil LC (2026), 0 descendants of its own

## Indications for use
3M VitCal Liner/Base is indicated for lining and basing applications under dental restorations. 3M VitCal Liner/Base is also indicated for direct pulp capping.

Source page: https://510kreport.com/device/K230270
Methodology: https://510kreport.com/methodology