510(k) · Cleared
ClearedCynovad Zirkon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cynovad · EIH Powder, Porcelain
Cleared on Dec 2, 2002 as substantially equivalent to K984201 (Dentronic AB, 1999) and 3 other predicates after a 59-day review. Its family tree reaches back 3 generations to 1983. 91 later devices descend from it.
- Decided
- Dec 2, 2002
- Review
- 59 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K830955 (1983). 10 ancestors in all. 91 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 2 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- 1 generation backK984201 DenzirDentronic AB · 1999
- This deviceK023327 Cynovad ZirkonCynovad · 2002
- Descendant · cites it directly · 80 of its ownK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- Descendant · cites it directly · 76 of its ownK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- Descendant · 2 generations on · 43 of its ownK081850 Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008
- Descendant · 3 generations on · 41 of its ownK093560 Upcera Zirconia BlanksShenyang Upcera Co., Ltd. · 2010
- Descendant · 4 generations on · 25 of its ownK141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankLiaoning Upcera Co., Ltd. · 2014
Showing 5 of 91 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 91 · See all- K043472Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005 · cites it directly80descendants
- K062695Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006 · cites it directly76descendants
- K081850Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008 · 2 generations on43descendants
- K093560Upcera Zirconia BlanksShenyang Upcera Co., Ltd. · 2010 · 3 generations on41descendants
- K141724Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankLiaoning Upcera Co., Ltd. · 2014 · 4 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −2 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| −1 | K984201 | Denzir | Dentronic AB | 1999 | — |
| 0 (this device) | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| +1 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| +1 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| +2 | K081850 | Bisque Zirconia Blanks, Type Byz | Zircar Zirconia, Inc. | 2008 | — |
| +3 | K093560 | Upcera Zirconia Blanks | Shenyang Upcera Co., Ltd. | 2010 | — |
| +4 | K141724 | Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Liaoning Upcera Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 8 | 0 |
| 2023 | 6 | 0 |
| 2024 | 9 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K984201 | DenzirSummary page 1…evices currently on the market, cleared by the T M . 510(k) process, Cynovad Zirkon IS basically identical with, Denzirm cleared under K984201 and Cercon Base cleared under K-013230, and very similar to "Zirconium Oxide for the DCS Precident CAD/CAM System" cleared in K-0… | 1999 |
| * | K013230 | Cercon BaseSummary page 1…by the T M . 510(k) process, Cynovad Zirkon IS basically identical with, Denzirm cleared under K984201 and Cercon Base cleared under K-013230, and very similar to "Zirconium Oxide for the DCS Precident CAD/CAM System" cleared in K-001875. It is also equivalent to the old… | 2001 |
| Kept off the family tree | K001875 | FDA’s K001875 is Diamedix IS-Rubella Igm Capture Test System Our reading of the summary gave K001875, FDA’s number for Diamedix IS-Rubella Igm Capture Test System (Diamedix Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Zirconium Oxide for the DCS Precident CAD/CAM System”. Kept off the family tree. Summary page 1…tical with, Denzirm cleared under K984201 and Cercon Base cleared under K-013230, and very similar to "Zirconium Oxide for the DCS Precident CAD/CAM System" cleared in K-001875. It is also equivalent to the older 'Vita Cerec Blocks" cleared under K895901. It is similar to "Dicor Ceramic Inlay," cleared by… | 2000 |
| * | K895901 | Vita Cerec Set and Vita Cerec BlocsSummary page 1…230, and very similar to "Zirconium Oxide for the DCS Precident CAD/CAM System" cleared in K-001875. It is also equivalent to the older 'Vita Cerec Blocks" cleared under K895901. It is similar to "Dicor Ceramic Inlay," cleared by Dentsply, lntl. under K884166. The "51O(k) "Substantial Equivalence" Decisio… | 1992 |
| * | K884166 | Dicor Ceramic Inlay - New TechnicSummary page 1…eared in K-001875. It is also equivalent to the older 'Vita Cerec Blocks" cleared under K895901. It is similar to "Dicor Ceramic Inlay," cleared by Dentsply, lntl. under K884166. The "51O(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as des… | 1989 |
| † | K950299 | CEREC 2 | 1995 |
| † | K972276 | Cerec 2 Crown Software | 1997 |
What descends from it? (91)
See all 916 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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K043472 (Medin Tech, 2005) has gone furthest, with 80 descendants of its own.
- 7 other devices also cite its predicate K984201.
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?
Intended for preparation of crowns, facings, veneers, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish.
For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations.
Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, 11, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023327 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023327: Cynovad Zirkon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023327
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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