# K060469: Optibond All-in-One

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Mar 28, 2006 after 33 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.
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) G-Bond: named in the summary without a submission number

## Indications for use
OptiBondAll-In-One is a self-etching adhesive which combines the ingredients needed for etching, priming, and bonding into a single adhesive solution and is used for direct situations, i.e., light-cured composite and compomer restorations, composite/ceramic/amalgam/metal repairs, cavity sealing for amalgam restorations, light-cured or dual-cured core build-ups, and indirection situations, i.e., veneers, porcelain, composite, and metal-based inlays, onlays, crowns, bridges, endodontic posts, and cavity sealing as a pretreatment for indirect restorations.

Source page: https://510kreport.com/device/K060469
Methodology: https://510kreport.com/methodology