# K012082: Optibond Solo Plus Activator

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Sep 20, 2001 after 79 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: 5 generations back to K931812 (1993). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982394: Prime & Bond NT Dual Cure Universal Dental Adhesive System, Dentsply Intl. (1998) Summary page 2.

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

## Indications for use
The intended use of OptiBond Solo Plus Activator is for bonding of core materials, resin cements, and cementation of posts and amalgams.

Source page: https://510kreport.com/device/K012082
Methodology: https://510kreport.com/methodology