# K011854: Tokuyama M-Bond

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama America, Inc.
- Decided: Sep 4, 2001 after 83 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K855211 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991711: Bistite II SC, Tokuyama America, Inc. (1999) Summary page 1.
- K960464: C & B Metabond (Modification), Parkell, Inc. (1996) Summary page 1.
- K933030: Panavia 21, Kuraray Co. (1994) Summary page 1.

## Indications for use
For use as a dental cement for adhesion and fixation between tooth and prosthesis, tooth and tooth, and between two or more prostheses.

Source page: https://510kreport.com/device/K011854
Methodology: https://510kreport.com/methodology