# K030588: Artegral and Polystar Selection

- Pathway: 510(k) (Traditional)
- Applicant: Merz Dental GmbH
- Decided: May 7, 2003 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: 1 generation back to K022300 (2002). 1 ancestor in all.
7 later devices descend from it; 4 cite 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)
- 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
- K060507: Valplast Yamahachi Teeth (2006), 3 descendants of its own
- K070591: Replica, Ortolux Top, Odipal, Odilux, Odident, Vitacrilic, Nature's Best, Dental Acrylic Teeth (2007), 2 descendants of its own
- K134015: M-PM-Disc (2014), 1 descendant of its own
- K101029: Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer Teeth (2010), 1 descendant of its own
- K191836: Ceramill A-Splint (2019), 0 descendants of its own

## Indications for use
Artegral, and Polystaa Selection preformed plastic teeth are prefabricated devices composed of polymethylmethacrylate and cross-linking co-polymers of methacrylic acid (IPN) intended for use as teeth in dentures.

Source page: https://510kreport.com/device/K030588
Methodology: https://510kreport.com/methodology