# K974486: Clearfil Liner Bond  2V

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray America, Inc.
- Decided: Jan 29, 1998 after 64 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: 4 generations back to K931812 (1993). 13 ancestors in all.
67 later devices descend from it; 2 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943170: Clearfil Liner Bond 2, Kuraray Company, Ltd. (1994) Summary page 1.
- K871636: Clearfil Porcelain Bond, Kuraray Co. (1987) Summary page 1.
- K943165: Clearfil Photo Bond, Kuraray Company, Ltd. (1994) Summary page 1.
- K943167: Clearfil New Bond, Kuraray Company, Ltd. (1994) Summary page 1.
- K942493: Scotchbond Multi-Purpose Plus Dental Adhesive System, 3M Company (1994) Summary page 1.
- K964525: Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator, Dentsply Intl. (1997) Summary page 1.
- K910860: All-Bond 2, Bisco, Inc. (1991) Summary page 1.
- K934690: Kerr Optibond, Modification, Kerr Corporation (Danbury) (1993) Summary page 1.
- (no number) Probond: named in the summary without a submission number

## Most influential descendants
- K990040: Clearfil SE Bond (1999), 64 descendants of its own
- K012442: Modification to Clearfil SE Bond (2001), 60 descendants of its own
- K032455: Panavia F 2.0 (2003), 34 descendants of its own
- K094007: Unicem (2010), 22 descendants of its own
- K100756: MALTA (2010), 19 descendants of its own

## Indications for use
1) Direct filling restorations using light-cure or chemical-cure composite resin 2) Bonded amalgam restorations 3) Treatment of hypersensitive and/or exposed root surfaces 4) Cavity sealing as a pretreatment for indirect restorations 5) Intraoral repairs of facing crowns using light-cure composite resin 6) Cementing laminate veneers, inlays and onlays made of porcelain (or composite resin) using composite resin cement

Source page: https://510kreport.com/device/K974486
Methodology: https://510kreport.com/methodology