# K131734: All-Bond Universal SC (Not Finalized)

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Apr 11, 2014 after 302 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: 1 generation back to K063780 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063780: Ace Bond SE, Bisco, Inc. (2007) Summary page 1.

## Indications for use
All-Bond Universal SC adhesive is used for: * Direct Restorations (e.g. resin-based composite, resin-modified glass ionomer, core build-ups) * Indirect Restorations (e.g. metal, glass, ceramics, zirconialalumlna) * Bonding Resin or Primer for Substrates * Desensitization/Sealing of Tooth * lntraoral Repair (e.g. chipped porcelain, additions to direct restorations)

Source page: https://510kreport.com/device/K131734
Methodology: https://510kreport.com/methodology