# K120404: Merz Dental GMBH Artegral HD Preformed Plastic Denture Teeth

- Pathway: 510(k) (Traditional)
- Applicant: Merz Dental GmbH
- Decided: May 21, 2012 after 102 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: 2 generations back to K022300 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030588: Artegral and Polystar Selection, Merz Dental GmbH (2003) Summary page 1.

## Indications for use
Artegral HO are posterior preformed plastic denture teeth for use in: * supra construction for combined, fixed removable dental prostheses * hybrid construction for implant-supported dental prostheses * cover denture * total prostheses * model cast prostheses * partial dentures

Source page: https://510kreport.com/device/K120404
Methodology: https://510kreport.com/methodology