# K020239: Touch&Bond-Plus

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Mar 20, 2002 after 56 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Optibond Solo Plus: named in the summary without a submission number
- (no number) Optibond Solo Plus 2: named in the summary without a submission number
- (no number) Clearfil SE Bond: named in the summary without a submission number
- (no number) Touch&Bond: named in the summary without a submission number

## Most influential descendants
- K151518: Brush&Bond Plus (2015), 0 descendants of its own

## 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 or cast alloy restorations that include but may not be limited to indirect composite or porcelain inlays and onlays, laminate veneers, either resin or porcelain, porcelain-fused-to-metal crowns, etc. 3. Treatment of hypersensitive areas of exposed root surfaces. 4. A cavity sealant and desensitizer applied to exposed dentin that has been prepared to receive a laboratory fabricated restoration such as porcelain-fused-to-metal crowns, cast alloy or tooth-colored inlays or onlays, veneers, etc.

Source page: https://510kreport.com/device/K020239
Methodology: https://510kreport.com/methodology