510(k) · Cleared
ClearedSagemax Z-Blank
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sagemax Bioceramics, Inc. · EIH Powder, Porcelain
Cleared on Oct 20, 2006 as substantially equivalent to K050903 (Wieland Dental + Technik GmbH & Co. KG, 2005) and 4 other predicates after a 39-day review. Its family tree reaches back 5 generations to 1983. 76 later devices descend from it.
- Decided
- Oct 20, 2006
- Review
- 39 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K830955 (1983). 13 ancestors in all. 76 later devices descend from it, 8 citing it directly.
- Root · 5 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 4 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- 3 generations backK984201 DenzirDentronic AB · 1999
- 2 generations backK023327 Cynovad ZirkonCynovad · 2002
- 1 generation backK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- This deviceK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- Descendant · cites it directly · 43 of its ownK081850 Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008
- Descendant · 2 generations on · 41 of its ownK093560 Upcera Zirconia BlanksShenyang Upcera Co., Ltd. · 2010
- Descendant · 3 generations on · 25 of its ownK141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankLiaoning Upcera Co., Ltd. · 2014
- Descendant · cites it directly · 17 of its ownK081263 StarceramH.C. Starck Ceramics GmbH & Co.Kg · 2008
- Descendant · 2 generations on · 13 of its ownK093748 DD Bio Z and DD Bio Z - TranspaDental Direkt of Amerika UG (Haftungsbeschraenkt) · 2010
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K081850Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008 · cites it directly43descendants
- K093560Upcera Zirconia BlanksShenyang Upcera Co., Ltd. · 2010 · 2 generations on41descendants
- K141724Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankLiaoning Upcera Co., Ltd. · 2014 · 3 generations on25descendants
- K081263StarceramH.C. Starck Ceramics GmbH & Co.Kg · 2008 · cites it directly17descendants
- K093748DD Bio Z and DD Bio Z - TranspaDental Direkt of Amerika UG (Haftungsbeschraenkt) · 2010 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −4 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| −3 | K984201 | Denzir | Dentronic AB | 1999 | — |
| −2 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| −1 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| 0 (this device) | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| +1 | K081850 | Bisque Zirconia Blanks, Type Byz | Zircar Zirconia, Inc. | 2008 | — |
| +2 | K093560 | Upcera Zirconia Blanks | Shenyang Upcera Co., Ltd. | 2010 | — |
| +3 | K141724 | Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Liaoning Upcera Co., Ltd. | 2014 | — |
| +1 | K081263 | Starceram | H.C. Starck Ceramics GmbH & Co.Kg | 2008 | — |
| +2 | K093748 | DD Bio Z and DD Bio Z - Transpa | Dental Direkt of Amerika UG (Haftungsbeschraenkt) | 2010 | — |
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 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 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 | 8 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050903 | Xawex G 100Summary page 1…evice ready for installation. Relative to devices currently on the market, cleared by the 510(k) process, Sagemax Z-Blank is substantially equivalent to Xavex cleared in K050903, to Medin Tech Zirconia CP10, 1000 TM cleared in K043472, and to Cynovad Zirkon cleared in K023327 and equivalent to DenzirM… | 2005 |
| * | K043472 | Medin Tech Zirconia-CP10, SS1000Summary page 1…ly on the market, cleared by the 510(k) process, Sagemax Z-Blank is substantially equivalent to Xavex cleared in K050903, to Medin Tech Zirconia CP10, 1000 TM cleared in K043472, and to Cynovad Zirkon cleared in K023327 and equivalent to DenzirM T (Dentronic AB) cleared under K984201 as well as Cercon… | 2005 |
| * | K023327 | Cynovad ZirkonSummary page 1…ocess, Sagemax Z-Blank is substantially equivalent to Xavex cleared in K050903, to Medin Tech Zirconia CP10, 1000 TM cleared in K043472, and to Cynovad Zirkon cleared in K023327 and equivalent to DenzirM T (Dentronic AB) cleared under K984201 as well as Cercon Base (Degussa Dental) cleared under K-013… | 2002 |
| * | K984201 | DenzirSummary page 1…n K050903, to Medin Tech Zirconia CP10, 1000 TM cleared in K043472, and to Cynovad Zirkon cleared in K023327 and equivalent to DenzirM T (Dentronic AB) cleared under K984201 as well as Cercon Base (Degussa Dental) cleared under K-013230. Like Cercon Base, it is TM intended to be… | 1999 |
| * | K013230 | Cercon BaseSummary page 1…2, and to Cynovad Zirkon cleared in K023327 and equivalent to DenzirM T (Dentronic AB) cleared under K984201 as well as Cercon Base (Degussa Dental) cleared under K-013230. Like Cercon Base, it is TM intended to be marketed as a partially sintered device which will then be machi… | 2001 |
| † | K001815 | DC Zirkon | 2000 |
| † | K950299 | CEREC 2 | 1995 |
| † | K972276 | Cerec 2 Crown Software | 1997 |
What descends from it? (76)
See all 768 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 23 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K081850 (Zircar Zirconia, Inc., 2008) has gone furthest, with 43 descendants of its own.
- 4 other devices also cite its predicate K050903.
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 use in preparation of crowns, facings, inlays and onlays-to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects, For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations. The suitability of high purity dense yttria tetragonal zirconium oxide has been well demonstrated for many uses in the dental industry
Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes 1,11, 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/K062695 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062695: Sagemax Z-Blank.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062695
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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