# K940459: Multipurpose Resin Cement with Fluoride (MRCF)

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Apr 29, 1994 after 87 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
No predicates in its family tree.
21 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K981965: Flowable Composite (1998), 11 descendants of its own
- K083841: Adaptable Composite Resin Restorative Material (2009), 9 descendants of its own
- K120453: Filtek Bulk Fill Flowable Restorative (2012), 8 descendants of its own
- K040906: Calibra Cement (2004), 8 descendants of its own
- K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer (2008), 3 descendants of its own

Source page: https://510kreport.com/device/K940459
Methodology: https://510kreport.com/methodology