# K011685: Bistite II DC

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama America, Inc.
- Decided: Jul 31, 2001 after 61 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.
3 later devices descend from it; 1 cites 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)
- K991711: Bistite II SC, Tokuyama America, Inc. (1999) Summary page 1.
- K933030: Panavia 21, Kuraray Co. (1994) Summary page 1.
- K960464: C & B Metabond (Modification), Parkell, Inc. (1996) Summary page 1.

## Most influential descendants
- K150727: Estecem (2015), 2 descendants of its own
- K171226: Tokuyama Universal Bond (2017), 1 descendant of its own
- K203760: Tokuyama Universal Bond II (2021), 0 descendants of its own

## Indications for use
For use as a dental cement in various applications, including luting, repair of fractured procelains or crown and bridge resins, cemtation of adhesive bridge prostheses and CR core posts.

Source page: https://510kreport.com/device/K011685
Methodology: https://510kreport.com/methodology