# K032179: COMP. E

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Sep 9, 2003 after 57 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) Special Bond: named in the summary without a submission number
- (no number) Special Bond II: named in the summary without a submission number

## Indications for use
For use in repairing, adding to, or otherwise modrfying the surface of resins. Especially useful for enhancing co-polymerization between an old and a new composite resin when the former requires refreshing or repair in order to extend its clinical life. May also be used as the primer of intaglio surfaces of indirect, resin-based restorations to enhance the bond of these with resin-based luting materials. This agent is also useful for bond enhancement of highly cross-linked denture teeth, acrylic or composite, to denture base resins. This material will improve the union between resin surfaces in a myriad of situations, both intra- and exta-orally.

Source page: https://510kreport.com/device/K032179
Methodology: https://510kreport.com/methodology