# K043312: Nobelrondo Dental Ceramic - Zirconia

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare USA, LLC
- Decided: Feb 1, 2005 after 62 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: 2 generations back to K944702 (1994). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041312: Nobelrondo Dental Ceramic-Alumina, Nobel Biocare Uas, Inc. (2004) Summary page 1.

## Most influential descendants
- K140848: Luminesse Porcelain System (2014), 2 descendants of its own
- K182350: Dental Ceramic (2019), 0 descendants of its own
- K163251: Life Essence Universal Porcelain System (2017), 0 descendants of its own

## Indications for use
NobelRondo Dental Ceramic Zirconia is a ceramic material intended for veneering substructures such as single crowns, multiple frameworks or abutments made from zirconia.

Source page: https://510kreport.com/device/K043312
Methodology: https://510kreport.com/methodology