# K140848: Luminesse Porcelain System

- Pathway: 510(k) (Traditional)
- Applicant: Talladium, Inc.
- Decided: Dec 17, 2014 after 258 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: 3 generations back to K944702 (1994). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040421: Duceragold Porcelains, Dentsply Intl. (2004) Summary page 4.
- K981490: Willi Geller Creation Porcelain, Jensen Industries, Inc. (1998) Summary page 4.
- K043312: Nobelrondo Dental Ceramic - Zirconia, Nobel Biocare USA, LLC (2005) Summary page 4.

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

## Indications for use
The Luminesse Porcelain System is dental porcelain material to be used in conjunction with metal, zirconia, or pressable ceramic framework in the construction of crowns and/or bridgework and veneers.

Source page: https://510kreport.com/device/K140848
Methodology: https://510kreport.com/methodology
