# K011908: Optibond Solo Plus 3

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Dental Materials Center
- Decided: Sep 6, 2001 after 79 days
- Product code: EBC (Sealant, Pit And Fissure, And Conditioner)
- Device class: 2
- Regulation: 21 CFR 872.3765
- 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. The FDA summary names its predicate without a number.
- (no number) Kerr Corporation, Guardian Seal: named in the summary without a submission number

## Indications for use
The intended use of OptiBond Solo Plus 3 is for bonding 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, pit and fissure sealant, and for indirect situations, i.e., veneers, onlays, inlays, crowns, post cementation.

Source page: https://510kreport.com/device/K011908
Methodology: https://510kreport.com/methodology