# K123265: Rmgi Low Viscosity

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Dec 7, 2012 after 49 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: 3 generations back to K933139 (1994). 9 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120784: Tuff-Temp 2.0, Pulpdent Corporation (2012) Summary page 2.
- K111185: Relyx Luting Plus Automix, 3M Espe Dental Products (2011) Summary page 2.
- K020117: GC Fuji Lining LC Paste Pak, GC America, Inc. (2002) Summary page 2.
- K051427: GC Fuji Fil LC, GC America, Inc. (2005) Summary page 2.
- K993973: Fuji II LC Capsule, GC America, Inc. (2000) Summary page 2.

## Cited in the summary but kept off the family tree
- K012000: 1.5MM Bone Fixation Kit, Bionx Implants, Ltd. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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
Pulpdent RA4GI Low Viscosity is a resin-modified glass lonomer preparation used by dental professionals as a liner, base or luting material in dental restorations.

Source page: https://510kreport.com/device/K123265
Methodology: https://510kreport.com/methodology