# K150727: Estecem

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama Dental Corporation
- Decided: Jun 17, 2015 after 89 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: 3 generations back to K855211 (1986). 5 ancestors in all.
2 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)
- K011685: Bistite II DC, Tokuyama America, Inc. (2001) Summary page 7.

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

## Indications for use
The ESTECEM device is an adhesive resin cement for the cementation of crowns, bridges, inlays, and onlays made of glass/oxide ceramics (porcelain, zirconia and alumina), metals/alloys (precious and non-precious) and resin materials including inorganic filler (composite materials). The ESTECEM device is indicated for: - Repair of fractured porcelain fused to metal crowns and all ceramic restorations - Cementation of veneers - Cementation of adhesion bridges - Cementation of metal or resin cores, metal or glass-fiber posts

Source page: https://510kreport.com/device/K150727
Methodology: https://510kreport.com/methodology