# K993917: Tokuyama One-UP-Bond F

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama America, Inc.
- Decided: Feb 2, 2000 after 77 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 K980058 (1998). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980058: Tokuso Mac Bond II, Tokuyama America, Inc. (1998) Summary page 1.

## Most influential descendants
- K023842: Clearfil SE Bond Plus (2003), 3 descendants of its own
- K183391: Novidia Universal Bond (2019), 0 descendants of its own
- K122522: Dentoetch Quickbond Bond Activator (2013), 0 descendants of its own
- K070956: SEA2 Self Etch Adhesive (2007), 0 descendants of its own

## Indications for use
For use in dental procedures as a bonding primer with light cured resin filling material to enhance the adhesion of resin filling material to the tooth and for sealing of exposed cervical dentin and root surfaces.

Source page: https://510kreport.com/device/K993917
Methodology: https://510kreport.com/methodology