# K231696: Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal

- Pathway: 510(k) (Traditional)
- Applicant: Prevest Denpro Limited
- Decided: Aug 11, 2023 after 60 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: 10 generations back to K931812 (1993). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110403: Prolink Adhesives (Prolink, Prolink SE), Silmet, Ltd. (2011) Summary page 6.
- K943165: Clearfil Photo Bond, Kuraray Company, Ltd. (1994) Summary page 6.
- K131432: Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack; Clearfil SE Bond 2 Bond; Clearfil, Kuraray Noritake Dental, Inc. (2013) Summary page 6.

## Indications for use
Fusion Bond 5 is indicated for direct composite or compomer restorations, adhesive cementation, and composite repair. Fusion Bond 7 is indicated for bonding of composites to tooth structure, core build up, and adhesive cementation of crown & bridges, including inlays and onlays. Fusion Bond DC is indicated for direct light cure composite or compomer restorations, core build up, and adhesive cementation of crown & bridges, including inlays and onlays. Renew MDP is indicated for bonding of dual cure, light cure or self cure composite or compomer restorations to tooth structure, treatment of hypersensitive teeth, and intraoral repairs of fractured restorations. Renew Universal is indicated for direct bonding of light-cured composites, and compomers to tooth structure, bonding of dual-cured core build up composites to tooth structure as long as these materials are light-cured, intraoral repair of composite, metal-based and zirconia /alumina-based restorations, intraoral repair of ceramic restorations in combination with a silane coupling agent, treatment of hypersensitive teeth, and cavity sealing as a pretreatment for indirect restorations.

Source page: https://510kreport.com/device/K231696
Methodology: https://510kreport.com/methodology