# K984043: Quadrant Total Etch

- Pathway: 510(k) (Traditional)
- Applicant: Cavex Holland BV
- Decided: Dec 4, 1998 after 21 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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
Quadrant Total Etch is used in the dental adhesive restorative technique for conditioning of enamel and dentin following the so-called “total etch technique”, prior to the use of a bonding agent such as Quadrant UniBond.. With this technique, numerous sites for mechanical retention on micro-scale will be created, forming an excellent basis for the bonding agent to penetrate, seal off the enamel and dentin surface and bond the composite restorative material to the cavity wall.

Source page: https://510kreport.com/device/K984043
Methodology: https://510kreport.com/methodology