# K043468: Willi Geller Creation II Porcelain

- Pathway: 510(k) (Abbreviated)
- Applicant: Jensen Int'L, Inc.
- Decided: Jan 12, 2005 after 27 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 K002904 (2000). 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)
- K002904: Willi Geller Creation and LF Porcelain, Jensen Industries, Inc. (2000) Summary page 1.

## Indications for use
Willi Geller Creation TI Porcelain is a ceramic material intended for veneering of titanium alloy cores and substructures to form dental restorations.

Source page: https://510kreport.com/device/K043468
Methodology: https://510kreport.com/methodology