# K033628: ARTIC

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Jan 16, 2004 after 58 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 K000213 (2000). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000213: Jeldent Basic Line, J.F. Jelenko & Co. (2000) Summary page 1.
- K011130: Premium, Heraeus Kulzer, Inc. (2001) 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
- 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
Artic line are artificial synthethic resin permanent teeth. The enamel and dentine layers of HK teerh are highly cross-linked and suit the rate of natural abrasion. The base of the tooth is less cross-linked to achieve optimum bonding between the tooth and the denture acrylic

Source page: https://510kreport.com/device/K033628
Methodology: https://510kreport.com/methodology