# K022476: Relyx Rmgip

- Pathway: 510(k) (Special)
- Applicant: 3M Company
- Decided: Aug 2, 2002 after 4 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 K933139 (1994). 2 ancestors in all.
15 later devices descend from it; 4 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)
- K933139: 3M Vitremer Luting Cement, 3M Company (1994) Summary page 1.
- K001730: GC Fujicem, GC America, Inc. (2000) Summary page 1.

## Most influential descendants
- K111185: Relyx Luting Plus Automix (2011), 10 descendants of its own
- K123265: Rmgi Low Viscosity (2012), 5 descendants of its own
- K130223: Rmgi Fill (2013), 4 descendants of its own
- K153249: Pulpdent Solo Flowable Composite with MCP (2016), 1 descendant of its own
- K121804: Provitemp, Dentotemp, Totalcem, Dentocem (2013), 1 descendant of its own

## Indications for use
Luting porcelain fused to metal crowns and bridges to tooth structure, amalgam, composite or glass ionomer core build ups; Luting metal inlays, onlays or crowns; Luting pre-fabricated and cast post cementation Luting orthodontic appliances Luting crowns made with all-alumina or all-zirconia cores such as ProceraB AllCeram

Source page: https://510kreport.com/device/K022476
Methodology: https://510kreport.com/methodology