# K100232: Luminesse ZR Blanks

- Pathway: 510(k) (Abbreviated)
- Applicant: Talladium, Inc.
- Decided: May 21, 2010 after 115 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K051705 (2005). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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) Summary page 1.
- K081749: Avante Z Zirconia (as)3 Blocks, Pentron Ceramics, Inc. (2008)
- K051705: Ips E.Max Cad/Ips E.Max Zircad, Ivoclar Vivadent, Inc. (2005)
- K013230: Cercon Base, Degussa - Ney Dental, Inc. (2001) Summary page 1.

## Recalls of this device
- Aug 6, 2020 · Class II · Z-2943-2020: The linear shrinkage on the zirconia blank disc s part label is incorrect. The average linear shrinkage found on the product label was outside the acceptable range. The acceptable average linear shrin

## Indications for use
Lurninesse ZR Blanks are intended for CAD/CAM fabrication of all-ceramic ( no metal ) dental restorations. Luminesse ZR Blanks are partially sintered Yttria stabilized zirconia blanks for use as CAD/CAM milling blanks. They are isostatically cold pressed so they can be milled using any compatible CAD/CAM machine such as Sirona IbLab by Sirona Dental Systems, LLC, Charlotte, NC or KaVO Everest by Kayo Dental, Lake Zurich, IL. After the ZR Blank is milled, it is sintered, causing the materials to density into a high strength ceramic material which is suitable for dental inlays, onlays, crowns and bridges.

Source page: https://510kreport.com/device/K100232
Methodology: https://510kreport.com/methodology