# K071158: Auralay Pit & Fissure Sealant

- Pathway: 510(k) (Traditional)
- Applicant: Denali Corporation
- Decided: Jun 5, 2007 after 41 days
- Product code: EBC (Sealant, Pit And Fissure, And Conditioner)
- Device class: 2
- Regulation: 21 CFR 872.3765
- 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 Plowable 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
AuraLay Pit & Fissure Sealant is used to seal the pits and fissures of teeth. AuraLay is comprised of hydrophilic resins and an HLB composition of fillers. Together these provide optimum properties for sealing and excellent tooth wetting. AuraLay has an extremely high compressive strength. This strength combined with excellent sealing and great esthetics make an excellent choice for sealing of teeth. AuraLay is available in different fluoride concentrations for different patient use.

Source page: https://510kreport.com/device/K071158
Methodology: https://510kreport.com/methodology