# K101029: Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer Teeth

- Pathway: 510(k) (Traditional)
- Applicant: Huge Dental Material Co., Ltd.
- Decided: Aug 16, 2010 after 125 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: 4 generations back to K022300 (2002). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061337: Wiedent Estetic, Xpdent Corp (2006) Summary page 1.
- K070591: Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic Teeth, Union Dental S.A./Unidesa.Odi (2007) Summary page 1.
- K022300: Acry Pan, Vipi Dent Plus, Biolux, Biolux V, New Dent, Dentoluxx, Vipi Dent N.H., Vipi Dent V, Dental Vipi Ltda (2002) Summary page 1.

## Most influential descendants
- K122955: Dentavit, Monarch, Acrotone, Senator, Dentorium (2013), 0 descendants of its own

## Indications for use
It is intended for use as a tooth in a denture. These teeth are used for making full or partial dentures. The artificial resin teeth are mounted on an appliance made of dental acrylic resin. The appliance is made to fit the patient's mouth and is a removable. It is not implanted.

Source page: https://510kreport.com/device/K101029
Methodology: https://510kreport.com/methodology