# K991808: Optibond Solo Plus 2

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Jul 9, 1999 after 43 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: 9 (0 Class I)
- 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) OptiBond Solo Plus: named in the summary without a submission number

## Most influential descendants
- K111431: B1P Adhesive (2011), 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
- Mar 3, 2006 · Not classified · Z-0686-06: The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
- Mar 3, 2006 · Not classified · Z-0691-06: The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
- Mar 3, 2006 · Not classified · Z-0690-06: The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
- Mar 3, 2006 · Not classified · Z-0687-06: The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
- Mar 3, 2006 · Not classified · Z-0688-06: The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
- Mar 3, 2006 · Not classified · Z-0689-06: The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
- Mar 3, 2006 · Not classified · Z-0692-06: The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
- Mar 3, 2006 · Not classified · Z-0693-06: The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.

## Indications for use
OptiBond Solo Plus 2 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 sealing, bonding composite core build-up materials, and indirect situations, i.e., veneers, onlays, inlays, crowns, (used in conjunction with a resin luting agent) post cementation.

Source page: https://510kreport.com/device/K991808
Methodology: https://510kreport.com/methodology