# K070215: Tokuyama Bond Force

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama Dental Corporation
- Decided: Mar 30, 2007 after 66 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 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 no predicate by number.

## Most influential descendants
- K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer (2008), 3 descendants of its own
- K161353: ESTELITE BULK FILL Flow (2017), 2 descendants of its own
- K171449: Metacem (2018), 1 descendant of its own
- K261166: Dia-Cem (2026), 0 descendants of its own
- K203598: Omnichroma Flow Bulk (2021), 0 descendants of its own

## Indications for use
The TOKUYAMA BOND FORCE resin tooth bonding agent device is intended for the bonding of light- or dual-cured composite material to (i) cut or uncut enamel, (ii) cut or uncut dentin, or (iii) fractured porcelain or composite for repair.

Source page: https://510kreport.com/device/K070215
Methodology: https://510kreport.com/methodology