# K946100: Fuji Duet

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jan 20, 1995 after 37 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.
12 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K012316: Permacem / Permacem Dual (2001), 5 descendants of its own
- K101869: Proglass Cements (One, Two Two LC, Nine, Plus, Silver) (2010), 3 descendants of its own
- K121804: Provitemp, Dentotemp, Totalcem, Dentocem (2013), 1 descendant of its own
- K041960: Composite/Compomer Repair Kit (2004), 1 descendant of its own
- K210473: Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) (2021), 0 descendants of its own

Source page: https://510kreport.com/device/K946100
Methodology: https://510kreport.com/methodology