# K143265: Acrylic Block

- Pathway: 510(k) (Traditional)
- Applicant: Sun Medical Co., Ltd.
- Decided: Apr 14, 2015 after 152 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- 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 K913655 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131036: Yamahachi Denture Base Resins, Yamahachi Dental Manufacturing Co. (2013) Summary page 4.

## Indications for use
Acrylic Block is a cured base acrylic resin that is indicated for use to fabricate a denture.

Source page: https://510kreport.com/device/K143265
Methodology: https://510kreport.com/methodology