# K970683: Zentih Flowable Composite (Multiple)

- Pathway: 510(k) (Traditional)
- Applicant: Foremost Dental Mfg., Inc.
- Decided: Jul 15, 1997 after 141 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K041960: Composite/Compomer Repair Kit (2004), 1 descendant of its own
- K063444: Total Etch Bonding Agent (2007), 0 descendants of its own

## Indications for use
Zenith Flowable Composite is a tooth-shaded resin filling material for use as an esthetic anterior restoration or base restoration under posterior or anterior composites, Federal law restricts this device to sale by, or on the order of a dentist, or other practitioner licensed by the law of the state in which he or she practices to use or order the use of this device.

Source page: https://510kreport.com/device/K970683
Methodology: https://510kreport.com/methodology