# K052235: LCR

- Pathway: 510(k) (Special)
- Applicant: 3M Company
- Decided: Sep 27, 2005 after 41 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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 K925032 (1992). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925032: 3M Vitremer Tri-Cure Glass Ionomer System, 3M Company (1992) Summary page 1.
- K925027: Photac-Fil Aplicap, Espe GmbH (Us) (1993) Summary page 1.
- K993973: Fuji II LC Capsule, GC America, Inc. (2000) Summary page 1.

## Most influential descendants
- K130223: Rmgi Fill (2013), 4 descendants of its own
- K153249: Pulpdent Solo Flowable Composite with MCP (2016), 1 descendant of its own
- K250953: Equia LC One (2025), 0 descendants of its own
- K210045: Activa Presto Pack (2021), 0 descendants of its own
- K192530: Surefil one Self-adhesive Composite Hybrid (2020), 0 descendants of its own

## Indications for use
Primary teeth restorations Small Class I restorations Class III and Class V restorations Transitional restorations Filling defects and undercut areas in crown preparations Core buildup where at least half the coronal tooth structure is remaining to provide structural support for the crown Laminate sandwich technique

Source page: https://510kreport.com/device/K052235
Methodology: https://510kreport.com/methodology