# K994302: Resin Tooth Bonding Agent

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Feb 7, 2000 after 48 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) Gluma One Bond: named in the summary without a submission number
- (no number) Clearfil SE Bond: named in the summary without a submission number
- (no number) Optibond Solo: named in the summary without a submission number

## Indications for use
This material is indicated for the following: 1. A dentin bonding agent used with direct filling materials that include but may not be limited to, composite resins, resin modified glass ionomers or compomers, etc. 2. A dentin bonding agent used with resin cements or composite luting agents to retain indirect tooth-colored restorations that include but may not be limited to indirect composite or porcelain inlays and onlays, lamin veneers, either resin or porcelain, etc. 3. Treatment of hypersensitive areas of exposed root surfaces. 4. A cavity sealant applied to exposed dentin that has been prepared to receive a laboratory fabricated restoration such as porcelain-fused-to-metal crowns, cast alloy inlays or onlays, etc.

Source page: https://510kreport.com/device/K994302
Methodology: https://510kreport.com/methodology