# K980058: Tokuso Mac Bond II

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama America, Inc.
- Decided: Apr 27, 1998 after 111 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 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)
- None. The FDA summary names its predicate without a number.
- (no number) Tokuso Light Bond: named in the summary without a submission number
- (no number) Scotchbond Adhesive System: named in the summary without a submission number
- (no number) Clearfil Liner Bond 2: named in the summary without a submission number

## Most influential descendants
- K993917: Tokuyama One-UP-Bond F (2000), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K980058
Methodology: https://510kreport.com/methodology