# K112806: Jensen Zirconia

- Pathway: 510(k) (Abbreviated)
- Applicant: Jensen Industries, Inc.
- Decided: Dec 1, 2011 after 65 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 K011394 (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)
- K011394: Lava Frame, Lava Frame Shade, Lava Ceram, Espe Dental AG (2001)

## Indications for use
Jensen Zirconia consists of pressed Zirconia - Yttrium blocks intended for milling of full contour crowns, crown and bridge substructures and implant super structures to produce prostheses for replacement of missing / damaged dentition,

Source page: https://510kreport.com/device/K112806
Methodology: https://510kreport.com/methodology