# K100150: CERAMICS2IN1

- Pathway: 510(k) (Traditional)
- Applicant: Biodenta Swiss AG
- Decided: May 25, 2010 after 126 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- 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 K011428 (2001). 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)
- K011428: Triceram, Dentaurum, Inc. (2001) Summary page 1.

## Indications for use
The dental ceramic ceramics2inl is a low fusing dental ceramic sinter material for the production of crowns and bridges made of zirconium oxide or titanium based coping and frameworks. The system comprises ceramic materials typical for dental ceramics: shoulder margin, opaque, opaque dentin, dentin, incisal, effect, opal, gingiva, addon correction material, stains, shades, glaze and liquids - Veneering of titanium copings / frameworks - Veneering of zirconium oxide based copings / frameworks

Source page: https://510kreport.com/device/K100150
Methodology: https://510kreport.com/methodology