# K151764: Yamahachi Pmma Disks

- Pathway: 510(k) (Traditional)
- Applicant: Yamahachi Dental Products USA, Inc.
- Decided: Nov 23, 2015 after 146 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- 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 K093708 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093708: Telio Cad, Ivoclar Vivadent, Inc. (2010) Summary page 5.

## Indications for use
YAMAHACHI PMMA DISKS are polymethyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered.

Source page: https://510kreport.com/device/K151764
Methodology: https://510kreport.com/methodology