# K991711: Bistite II SC

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama America, Inc.
- Decided: Jul 7, 1999 after 49 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: 1 generation back to K855211 (1986). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933030: Panavia 21, Kuraray Co. (1994) Summary page 1.
- K855211: Panavia EX, a Dental Adhesive, Kuraray Co. (1986) Summary page 1.
- K960464: C & B Metabond (Modification), Parkell, Inc. (1996) Summary page 1.

## Most influential descendants
- K011685: Bistite II DC (2001), 3 descendants of its own
- 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
- K011854: Tokuyama M-Bond (2001), 0 descendants of its own

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

Source page: https://510kreport.com/device/K991711
Methodology: https://510kreport.com/methodology