# K131036: Yamahachi Denture Base Resins

- Pathway: 510(k) (Traditional)
- Applicant: Yamahachi Dental Manufacturing Co.
- Decided: Jul 12, 2013 after 88 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: 2 generations back to K913655 (1991). 5 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K102874: New Stetic Acrylics, New Stetic (2011) Summary page 1.
- K102640: Vertex Self Curing, Vertex Castavaria, Vertex Castapress, Vertex-Dental B.V. (2011) Summary page 1.

## Most influential descendants
- K233859: Basis Flow II (2024), 0 descendants of its own
- K143265: Acrylic Block (2015), 0 descendants of its own

## Indications for use
Yamahachi Denture Base Resins is intended for fabrication or repair of the denture base. All devices are sold by or on the order of aphysician. They are notfor use by the generalpublic or over-the-counter.

Source page: https://510kreport.com/device/K131036
Methodology: https://510kreport.com/methodology