510(k) · Cleared
ClearedPrismatik Clinical Zirconia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Glidewell Laboratories · EIH Powder, Porcelain
Cleared on Mar 15, 2006 after a 61-day review. The FDA summary names its predicate without a number. 19 later devices descend from it.
- Decided
- Mar 15, 2006
- Review
- 61 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 5 citing it directly.
- This deviceK060104 Prismatik Clinical ZirconiaGlidewell Laboratories · 2006
- Descendant · cites it directly · 12 of its ownK130924 Bruxzir ShadedPrismatik Dentalcraft, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 6 of its ownK143330 BruxZir AnteriorPrismatik Dentalcraft, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK213425 BruxZir EstheticPrismatik Dentalcraft, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK123545 Incoris TziSirona Dental Systems GmbH · 2013
- Descendant · 3 generations on · 1 of its ownK162888 CerconDentsply Sirona · 2017
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K130924Bruxzir ShadedPrismatik Dentalcraft, Inc. · 2013 · cites it directly12descendants
- K143330BruxZir AnteriorPrismatik Dentalcraft, Inc. · 2014 · 2 generations on6descendants
- K213425BruxZir EstheticPrismatik Dentalcraft, Inc. · 2021 · 2 generations on2descendants
- K123545Incoris TziSirona Dental Systems GmbH · 2013 · cites it directly2descendants
- K162888CerconDentsply Sirona · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060104 | Prismatik Clinical Zirconia | Glidewell Laboratories | 2006 | — |
| +1 | K130924 | Bruxzir Shaded | Prismatik Dentalcraft, Inc. | 2013 | 1 |
| +2 | K143330 | BruxZir Anterior | Prismatik Dentalcraft, Inc. | 2014 | — |
| +2 | K213425 | BruxZir Esthetic | Prismatik Dentalcraft, Inc. | 2021 | — |
| +1 | K123545 | Incoris Tzi | Sirona Dental Systems GmbH | 2013 | — |
| +3 | K162888 | Cercon | Dentsply Sirona | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | — | CerconEg base (Dentsply) Named without a submission number | |
| * | — | LavaTrm Frame (3M) Named without a submission number | |
| * | — | IPS e~max ZirCAD (Ivoclar-Vivadent) Named without a submission number |
What descends from it? (19)
See all 195 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?
- Of its descendants, K130924 (Prismatik Dentalcraft, Inc., 2013) has gone furthest, with 12 descendants of its own.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
For use in prosthetic dentistry to create porcelain (ceramic) prostheses.
For use only by or on the order of a dental professional such as a DDS or DMD. Not for use by the general public or OTC.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060104 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060104: Prismatik Clinical Zirconia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060104
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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