# K093484: Premise Flowable Modified

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Corporation
- Decided: Jan 27, 2010 after 79 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) Premise Flowable: named in the summary without a submission number

## Indications for use
Premise Flowable Modified is a nano-filled, light cure, resin dental restorative suitable for Class I - V restorations. Additional functions include: base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occiusal build-ups in non-stress bearing area, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions and core build-ups.

Source page: https://510kreport.com/device/K093484
Methodology: https://510kreport.com/methodology