# K203760: Tokuyama Universal Bond II

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama Dental Corporation
- Decided: May 25, 2021 after 153 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: 8 generations back to K900510 (1990). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171226: Tokuyama Universal Bond, Tokuyama Dental Corporation (2017) Summary page 8.

## Indications for use
The TOKUYAMA UNIVERSAL BOND II is indicated for: - Direct anterior and posterior restorations with light-curing, dual-curing, and self-curing composite materials - Intraoral repair of composite restorations, porcelain fused to metal, metal, and all-ceramic restorations without an additional primer - Cementation of indirect restorations and veneers when combined with light-cure, dual-cure, and self-curing resin cements - Bonding of core build-ups made of core build-up materials - Bonding of denture resin to metal base, clasp or attachment - Repair of denture with metal base, clasp or attachment - Bonding of opaque resin to a metal base in the fabrication of resin-faced crowns

Source page: https://510kreport.com/device/K203760
Methodology: https://510kreport.com/methodology