# K050838: The LF-P Ceramic System

- Pathway: 510(k) (Abbreviated)
- Applicant: Jensen Industries, Inc.
- Decided: May 4, 2005 after 33 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 K830955 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971869: Finesse All-Ceramic System, Dentsply Intl. (1997) Summary page 1.
- K002904: Willi Geller Creation and LF Porcelain, Jensen Industries, Inc. (2000) Summary page 1.

## Indications for use
the LF-P Ceramic System is a ceramic material formed into pellets intended for pressing into full contour restorations (crowns, onlays, inlays and veneers) and substructures as well as pressing to conventional precious and non-precious metal substructures. The system also includes low fusion ceramics suitable for layering or stain / glaze finishing.

Source page: https://510kreport.com/device/K050838
Methodology: https://510kreport.com/methodology