# K131043: Apex Universal Adhesive

- Pathway: 510(k) (Traditional)
- Applicant: Apex Dental Materials, Inc.
- Decided: Sep 10, 2013 after 148 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
Apex Universal Adhesive is a single component bonding system for: * Direct Restorations: to seal enamel / dentin prior to restoring with light-cure or self-cure composite material * Indirect Restorations: bonding light-cured, self-cured or dual-cured composite cements or glass lonomer or resin-modified glass ionomer cements * Bonding CERECO restorations * Desensitization: to treat hypersensitive and / or exposed root surfaces * Desensitizing crown preparations * Sealing preparations before placing amalgams * Bonding crowns and bridges * Bonding in posts and cores * Bonding veneers

Source page: https://510kreport.com/device/K131043
Methodology: https://510kreport.com/methodology