# K130223: Rmgi Fill

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Mar 29, 2013 after 59 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: 4 generations back to K933139 (1994). 13 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123265: Rmgi Low Viscosity, Pulpdent Corporation (2012) Summary page 2.
- K052235: LCR, 3M Company (2005) Summary page 2.
- K051427: GC Fuji Fil LC, GC America, Inc. (2005) Summary page 2.

## Most influential descendants
- 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
Pulpdent RMGI Fill is a resin-modified glass ionomer preparation used by dental professionals as filling material in dental restorations.

Source page: https://510kreport.com/device/K130223
Methodology: https://510kreport.com/methodology