# K063444: Total Etch Bonding Agent

- Pathway: 510(k) (Abbreviated)
- Applicant: Dmg USA, Inc.
- Decided: Mar 20, 2007 after 125 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
Longest line of descent: 7 generations back to K931812 (1993). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003293: Excite DSC, Ivoclar North America, Inc. (2001) Summary page 1.
- K910628: All Bond Liner-F, Bisco, Inc. (1991) Summary page 1.
- K942493: Scotchbond Multi-Purpose Plus Dental Adhesive System, 3M Company (1994) Summary page 1.
- K041960: Composite/Compomer Repair Kit, Dmg USA, Inc. (2004) Summary page 2.
- (no number) Optibond Solo Plus (Dual-cure): named in the summary without a submission number

## Indications for use
Total-Etch Dualbond is indicated for: * Bonding resin-based materials (especially dual-cure composite / compomer materials) to tooth structure (dentin and enamel) * Treatment of hypersensitive teeth Total-Etch Bond is indicated for: * Bonding resin-based materials (especially light-cure composite / compomer materials) to tooth structure (dentin and enamel) * Treatment of hypersensitive teeth

Source page: https://510kreport.com/device/K063444
Methodology: https://510kreport.com/methodology