# K962515: Kerr Advanced Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Dental Materials Center
- Decided: Aug 1, 1996 after 35 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- 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) Prime & Bond: named in the summary without a submission number
- (no number) One-Step: named in the summary without a submission number
- (no number) Tenure QUIK: named in the summary without a submission number

## Indications for use
Kerr Advanced Adhesive is an all purpose dental adhesive consisting of a visible light curable methacrylate resin based mixture of monomers capable of forming both chemical and mechanical adhesive bonds to both natural tooth structures ( enamel and dentin ) and to commonly used restorative materials ( composite resins, porcelain and metals ). It is supplied as a one bottle, single step dental adhesive that is simple to use and produces fast, strong adhesion suitable for all commonly used restorative techniques. The organic solvent component allows the application of the adhesive to flow into micro-fissures of the substrate smoothly and when the fast evaporating solvent is removed a thin resin layer remains to form a tight bonding interface between tooth and restorative material.

Source page: https://510kreport.com/device/K962515
Methodology: https://510kreport.com/methodology