510(k) · Cleared
Recalled · Class II · 2020Luminesse ZR Blanks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Talladium, Inc. · EIH Powder, Porcelain
Cleared on May 21, 2010 as substantially equivalent to K011394 (Espe Dental AG, 2001) and 3 other predicates after a 115-day review. Its family tree reaches back 2 generations to 2005. It has been recalled once.
- Decided
- May 21, 2010
- Review
- 115 days
- Class
- Class II
- Product code
- EIH
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K051705 (2005). 5 ancestors in all, the oldest K011394 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051705 | Ips E.Max Cad/Ips E.Max Zircad | Ivoclar Vivadent, Inc. | 2005 | 10 |
| −1 | K081749 | Avante Z Zirconia (as)3 Blocks | Pentron Ceramics, Inc. | 2008 | — |
| 0 (this device) | K100232 | Luminesse ZR Blanks | Talladium, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EIH device
- #1 K192231 Dental Glass Ceramics Blocksscore 15.3 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011394 | Lava Frame, Lava Frame Shade, Lava CeramSummary page 1…ation Panel: Dental Devices CDRH Product Code: EJH Regulatory Class: II Predicate Devices: 1. LAVA FRAME by 3M ESPE (K0 11394) 2. Avante Z Zirconia by Pentron Ceramics (KO8 1749) 3. IPS e.max… | 2001 |
| * | K081749 | Avante Z Zirconia (as)3 Blocks | 2008 |
| * | K051705 | Ips E.Max Cad/Ips E.Max Zircad | 2005 |
| * | K013230 | Cercon BaseSummary page 1…ramics (KO8 1749) 3. IPS e.max ZirCAD by Ivoclar Vivadent AG (KO5 1705) 4. Cercon Base by Degussa Dental (K0 13230) Device Description: Luminesse Zirconia blanks, are high purity, bisque fired zircon… | 2001 |
| † | K950299 | CEREC 2 | 1995 |
| † | K972276 | Cerec 2 Crown Software | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 6, 2020 | Class II | Z-2943-2020 | Under Investigation by firm | 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 shrinkage ranges between 1.225 to 1.275.… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 14 other devices also cite its predicate K011394.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · EIH
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIH
84in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIH
1in 2025
MAUDE reports naming product code EIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 63 | 0 | 0 |
| 2008 | 15 | 87 | 0 | 1 |
| 2009 | 15 | 79 | 0 | 0 |
| 2010 | 14 | 89 | 0 | 0 |
| 2011 | 14 | 80 | 0 | 1 |
| 2012 | 9 | 96 | 0 | 0 |
| 2013 | 16 | 107 | 0 | 6 |
| 2014 | 18 | 118 | 0 | 1 |
| 2015 | 23 | 118 | 0 | 0 |
| 2016 | 22 | 187 | 21 | 4 |
| 2017 | 16 | 149 | 0 | 1 |
| 2018 | 10 | 139 | 0 | 2 |
| 2019 | 16 | 125 | 0 | 1 |
| 2020 | 13 | 155 | 0 | 0 |
| 2021 | 17 | 131 | 0 | 22 |
| 2022 | 16 | 89 | 0 | 0 |
| 2023 | 15 | 114 | 0 | 0 |
| 2024 | 28 | 89 | 0 | 7 |
| 2025 | 13 | 84 | 1 | 1 |
| 2026 | 14 | 73 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100232 · printed Nov 3, 2026
Cite this page
510(k) Report. “K100232: Luminesse ZR Blanks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K100232
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026