510(k) · Cleared
ClearedIncoris Tzi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · EIH Powder, Porcelain
Cleared on Feb 1, 2013 as substantially equivalent to K060104 (Glidewell Laboratories, 2006) after a 74-day review. Its family tree reaches back 1 generation to 2006. 2 later devices descend from it.
- Decided
- Feb 1, 2013
- Review
- 74 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K060104 (2006). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK060104 Prismatik Clinical ZirconiaGlidewell Laboratories · 2006
- This deviceK123545 Incoris TziSirona Dental Systems GmbH · 2013
- Descendant · cites it directly · 0 of its ownK242462 CEREC Cercon 4D CAD/CAM BlocksDentsply Sirona · 2024
- Descendant · cites it directly · 0 of its ownK151875 Pavati ZirconiaCcri, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K060104 | Prismatik Clinical Zirconia | Glidewell Laboratories | 2006 | — |
| 0 (this device) | K123545 | Incoris Tzi | Sirona Dental Systems GmbH | 2013 | — |
| +1 | K242462 | CEREC Cercon 4D CAD/CAM Blocks | Dentsply Sirona | 2024 | — |
| +1 | K151875 | Pavati Zirconia | Ccri, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2024 | 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 15.2 · 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? (1)
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 |
|---|---|---|---|
| * | K060104 | Prismatik Clinical ZirconiaSummary page 1…e: Powder, Porcelain Classification Name: Porcelain powder for clinical use 3. Predicate Devices Glidewell's PrismatikTm Clinical Zirconia (PrismatikTm CZ) (K060104) 4. Intended Use Classic and Speed Sintering: Fully anatomic crowns and bridges in the posterior and anterior tooth region… | 2006 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Classic and Speed.Sintering:
Fully anatomic crowns and bridges in the posterior and anterior tooth region.
Bridges with max. two pontics.
Super Speed Sintering:
Fully anatomic crowns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123545: Incoris Tzi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123545
Report an extraction error
Are you the manufacturer?
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