# K990040: Clearfil SE Bond

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Co.
- Decided: Feb 4, 1999 after 29 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: 5 generations back to K931812 (1993). 15 ancestors in all.
64 later devices descend from it; 5 cite it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974486: Clearfil Liner Bond  2V, Kuraray America, Inc. (1998) Summary page 1.
- K943170: Clearfil Liner Bond 2, Kuraray Company, Ltd. (1994) Summary page 1.
- K943165: Clearfil Photo Bond, Kuraray Company, Ltd. (1994) Summary page 1.
- K964525: Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator, Dentsply Intl. (1997) Summary page 1.
- K974390: Gluma One Bond, Heraeus Kulzer, Inc. (1998) 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) One Step Universal Dental Adhesive System: named in the summary without a submission number

## Most influential descendants
- 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
- K063593: Clearfil Majesty Flow (2007), 17 descendants of its own

## Indications for use
CLEARFIL SE BOND is indicated for the following applications: 1) Direct filling restorations using light-curing composite or compomer 2) Cavity sealing as a pretreatment for indirect restorations 3) Treatment of hypersensitive and/or exposed root surfaces 4) Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics and cured composite resin 5) Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin

Source page: https://510kreport.com/device/K990040
Methodology: https://510kreport.com/methodology