# K022973: Adhesive 14

- Pathway: 510(k) (Traditional)
- Applicant: Ab Ardent
- Decided: Nov 22, 2002 after 77 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
ADHESIVE 14 is to be used as a bonding agent for light curing composites and compomers to dentine tooth structure. The placement of Adhesive 14 is contraindicated if the patient is known to be allergic to the components of Adhesive 14. For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.

Source page: https://510kreport.com/device/K022973
Methodology: https://510kreport.com/methodology