# K060472: Premise Flowable

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Corporation
- Decided: Apr 28, 2006 after 64 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: 42 (0 Class I)
- 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) Point 4 Flowable: named in the summary without a submission number

## Recalls of this device
- Sep 5, 2008 · Not classified · Z-0231-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0232-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0241-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0242-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0243-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0247-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0248-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0249-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0250-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0251-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0253-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0255-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0256-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0258-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0259-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0261-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0267-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0236-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0239-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0244-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0245-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0257-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0266-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0268-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0229-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0230-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0234-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0265-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0269-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0233-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0235-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0237-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0238-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0240-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0246-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0252-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0254-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0260-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0262-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0263-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0264-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
- Sep 5, 2008 · Not classified · Z-0270-2009: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.

## Indications for use
Premise Flowable 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 :estorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, (..,ment for ceramic/composite veneers, incisal abrasions, and core build-ups.

Source page: https://510kreport.com/device/K060472
Methodology: https://510kreport.com/methodology