# K971594: Flow-Rite

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corp.
- Decided: Sep 12, 1997 after 134 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Pulpdent OBA: named in the summary without a submission number
- (no number) Seal-Rite: named in the summary without a submission number
- (no number) Seal-Rite Low Viscosity: named in the summary without a submission number
- (no number) Pulpdent Hybrid Anterior Composite: named in the summary without a submission number
- (no number) Bisco Aeliteflo: named in the summary without a submission number
- (no number) E&D / Kerr Revolution: named in the summary without a submission number

## Indications for use
PULPDENT FLOW-RITE is a visible light cured flowable composite paste used as a Class I, II, IV and V restorative. It dispenses as a smooth paste with excellent working properties and translucency for matching, blending and depth of cure. It cures in 30-40 seconds, is color stable and polishes beautifully.

Source page: https://510kreport.com/device/K971594
Methodology: https://510kreport.com/methodology