# K011211: Flowable Composite/ Ecuflow/ Luxaflow

- Pathway: 510(k) (Traditional)
- Applicant: Dmg USA, Inc.
- Decided: Jun 18, 2001 after 60 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
0 of 14 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
- K013674: Luxatemp/Luxatemp Solar/Instatemp (2002), 11 descendants of its own
- K101710: Luxatemp Ultra /Star (2010), 7 descendants of its own
- K073296: TEMPXN28 (2008), 4 descendants of its own
- K200039: P pro Crown & Bridge (2020), 1 descendant of its own
- K251271: TempFIT Temporary Crown and Bridge Resin (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K011211
Methodology: https://510kreport.com/methodology