# K122925: New Stetic Artificial Teeth

- Pathway: 510(k) (Traditional)
- Applicant: New Stetic
- Decided: Feb 12, 2013 after 141 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 K931162 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931162: King-Hue, Royal Coral, Super-C Artificial Teeth, King Dental Corp. (1993) Summary page 1.

## Indications for use
A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.

Source page: https://510kreport.com/device/K122925
Methodology: https://510kreport.com/methodology