# K014027: Optibond Solo Plus 4

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Dental Materials Center
- Decided: Feb 22, 2002 after 78 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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) Clearfil Liner Bond 2V: named in the summary without a submission number

## Most influential descendants
- K023842: Clearfil SE Bond Plus (2003), 3 descendants of its own
- K183391: Novidia Universal Bond (2019), 0 descendants of its own
- K122522: Dentoetch Quickbond Bond Activator (2013), 0 descendants of its own
- K070956: SEA2 Self Etch Adhesive (2007), 0 descendants of its own
- K040952: Prelude (2004), 0 descendants of its own

## Recalls of this device
- Aug 29, 2006 · Not classified · Z-1521-06: Mis-pack/mis-label: The OptiBond Self Etch Primer and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in reverse order. Application of these products in reverse order may res

## Indications for use
The intended use of Optibond Solo Plus 4 can be used for direct situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam sealing, post and core build-up materials, and indirect situations, i.e., veneers, onlays, inlays, crowns and bridges (used in conjunction with a resin luting agent).

Source page: https://510kreport.com/device/K014027
Methodology: https://510kreport.com/methodology