# K990498: Optibond Solo Plus

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Mar 8, 1999 after 19 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) Prime & Bond 2.1: named in the summary without a submission number

## Most influential descendants
- K040952: Prelude (2004), 0 descendants of its own

## Indications for use
OptiBond Solo Plus is a multi-purpose bonding agent designed to be used in direct situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam bonding, bonding composite core build-up materials, and indirect situations, i.e., veneers, onlays, inlays, crowns, Maryland bridges, post cementation.

Source page: https://510kreport.com/device/K990498
Methodology: https://510kreport.com/methodology