# K060507: Valplast Yamahachi Teeth

- Pathway: 510(k) (Traditional)
- Applicant: Valplast Intl. Corp.
- Decided: Apr 7, 2006 after 39 days
- Product code: ELM (Denture, Plastic, Teeth)
- Device class: 2
- Regulation: 21 CFR 872.3590
- 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 K022300 (2002). 5 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K033628: ARTIC, Heraeus Kulzer, Inc. (2004) Summary page 1.
- K030588: Artegral and Polystar Selection, Merz Dental GmbH (2003) Summary page 1.

## Most influential descendants
- K070591: Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic Teeth (2007), 2 descendants of its own
- K101029: Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer Teeth (2010), 1 descendant of its own
- K122955: Dentavit, Monarch, Acrotone, Senator, Dentorium (2013), 0 descendants of its own

## Indications for use
The Valplast International Corporation Yamahachi Teeth are prefabricated, preformed plastic teeth that are intended for use as teeth in removable dentures.

Source page: https://510kreport.com/device/K060507
Methodology: https://510kreport.com/methodology