# K070693: Auravue Pit & Fissure Sealant

- Pathway: 510(k) (Traditional)
- Applicant: Denali Corporation
- Decided: May 9, 2007 after 57 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) CosineSeal Pit and Fissure Sealant: named in the summary without a submission number
- (no number) UltraSeal XT Pit and Fissure Sealant and Flowable Composite Kit: named in the summary without a submission number
- (no number) Delton Clear Pit and Fissure Sealant Kit: named in the summary without a submission number

## Indications for use
AuraVue is a clear pit and fissure sealant. Because this material is clear this allows observation of the tooth surface. AuraVue is color stable which allows the material to be indicative of conditions which may occur beneath the sealant. This would include possible leakage, staining and also allows the use of caries detecting devices. AuraVue has excellent sealing ability and has demonstrated clinical success as a sealant. AuraVue is recommended for pit and fissure application and for minimally invasive dentistry. AuraVue is also recommended for sealing of composite enamel margins and as a composite sealer. AuraVue is available in both fluoride and non-fluoride releasing formulas.

Source page: https://510kreport.com/device/K070693
Methodology: https://510kreport.com/methodology