# K122955: Dentavit, Monarch, Acrotone, Senator, Dentorium

- Pathway: 510(k) (Abbreviated)
- Applicant: Wright Health Group, Ltd.
- Decided: Mar 1, 2013 after 157 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: 5 generations back to K022300 (2002). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K914476: Vitapan Acrylic Denture Teeth, Vident (1992) Summary page 1.
- K101029: Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer Teeth, Huge Dental Material Co., Ltd. (2010) Summary page 1.

## Indications for use
These dental plastic teeth are parts used for denture fabrication. PMMA is mixed with monomer in a polymerization process. The plastic teeth are part of dentures made to fit a patient's mouth which are removable or may be attached to dental implant devices.

Source page: https://510kreport.com/device/K122955
Methodology: https://510kreport.com/methodology