# K070591: Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic Teeth

- Pathway: 510(k) (Traditional)
- Applicant: Union Dental S.A./Unidesa.Odi
- Decided: May 11, 2007 after 71 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: 3 generations back to K022300 (2002). 10 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K033628: ARTIC, Heraeus Kulzer, Inc. (2004) Summary page 1.
- K792245: Teeth, Denture, Plastic, Dentsply Intl. (1980) Summary page 1.
- K915276: Denture Plastic Teeth,76 Elm, Nobelpharma USA, Inc. (1992) Summary page 1.
- K060507: Valplast Yamahachi Teeth, Valplast Intl. Corp. (2006) Summary page 1.
- K030588: Artegral and Polystar Selection, Merz Dental GmbH (2003). Our OCR of the scanned summary read K130588, FDA’s number for Merit Hydrophilic Guide Wire (Merit Medical Systems, Inc.), decided Apr 5, 2013, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Artegral and Polystar Selection teeth”.
- K022299: Trilux, Z-Tone, Acry Rock, Ruthibras Imp. Exp. Com. DE Materiais Odontologico (2002) 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.
- K061337: Wiedent Estetic, Xpdent Corp (2006) Summary page 1.

## Most influential descendants
- 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
Teeth for the fabrication of dentures 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 patients mouth and is a removable. It is not implanted.

Source page: https://510kreport.com/device/K070591
Methodology: https://510kreport.com/methodology