# K922249: Flexi-Flow Cement Natural

- Pathway: 510(k) (Traditional)
- Applicant: Essential Dental Systems, Inc.
- Decided: Jan 26, 1994 after 630 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 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
- K121804: Provitemp, Dentotemp, Totalcem, Dentocem (2013), 1 descendant of its own
- K041960: Composite/Compomer Repair Kit (2004), 1 descendant of its own
- K162960: TotalC-Ram (2017), 0 descendants of its own
- K063444: Total Etch Bonding Agent (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K922249
Methodology: https://510kreport.com/methodology