510(k) · Cleared
ClearedBisque Zirconia Blanks, Type Byz
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zircar Zirconia, Inc. · EIH Powder, Porcelain
Cleared on Sep 25, 2008 as substantially equivalent to K062695 (Sagemax Bioceramics, Inc., 2006) and 1 other predicate after an 87-day review. Its family tree reaches back 6 generations to 1983. 43 later devices descend from it.
- Decided
- Sep 25, 2008
- Review
- 87 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K830955 (1983). 15 ancestors in all. 43 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 5 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- 4 generations backK984201 DenzirDentronic AB · 1999
- 3 generations backK023327 Cynovad ZirkonCynovad · 2002
- 2 generations backK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- 1 generation backK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- This deviceK081850 Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008
- Descendant · cites it directly · 41 of its ownK093560 Upcera Zirconia BlanksShenyang Upcera Co., Ltd. · 2010
- Descendant · 2 generations on · 25 of its ownK141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankLiaoning Upcera Co., Ltd. · 2014
- Descendant · 2 generations on · 7 of its ownK111291 Aidite Zirconia Dental CeramicsQinhuangdao Aidite High-Technical Ceramics Co, Ltd. · 2011
- Descendant · 3 generations on · 6 of its ownK160367 Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankNissin-Metec China Co., Ltd. · 2016
- Descendant · 3 generations on · 4 of its ownK203590 Perfit FS Dental Zirconia Fully Sintered BlockVatech Acucera, Inc. · 2021
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K093560Upcera Zirconia BlanksShenyang Upcera Co., Ltd. · 2010 · cites it directly41descendants
- K141724Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankLiaoning Upcera Co., Ltd. · 2014 · 2 generations on25descendants
- K111291Aidite Zirconia Dental CeramicsQinhuangdao Aidite High-Technical Ceramics Co, Ltd. · 2011 · 2 generations on7descendants
- K160367Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankNissin-Metec China Co., Ltd. · 2016 · 3 generations on6descendants
- K203590Perfit FS Dental Zirconia Fully Sintered BlockVatech Acucera, Inc. · 2021 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −5 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| −4 | K984201 | Denzir | Dentronic AB | 1999 | — |
| −3 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| −2 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| −1 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| 0 (this device) | K081850 | Bisque Zirconia Blanks, Type Byz | Zircar Zirconia, Inc. | 2008 | — |
| +1 | K093560 | Upcera Zirconia Blanks | Shenyang Upcera Co., Ltd. | 2010 | — |
| +2 | K141724 | Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Liaoning Upcera Co., Ltd. | 2014 | — |
| +2 | K111291 | Aidite Zirconia Dental Ceramics | Qinhuangdao Aidite High-Technical Ceramics Co, Ltd. | 2011 | — |
| +3 | K160367 | Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Nissin-Metec China Co., Ltd. | 2016 | — |
| +3 | K203590 | Perfit FS Dental Zirconia Fully Sintered Block | Vatech Acucera, Inc. | 2021 | — |
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 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 8 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K062695 | Sagemax Z-BlankSummary page 2…dental professional. They are not for use by the general public or over-the-counter. Predicate Devices: 1. Sagemax Z-Blank (K062695) 2. Vita In-Cream YZ Cubes for Cerec (K022996) Safety and Effectiveness: By definition, a device i… | 2006 |
| * | K022996 | Vita in-Ceram YZ Cubes for CerecSummary page 2…general public or over-the-counter. Predicate Devices: 1. Sagemax Z-Blank (K062695) 2. Vita In-Cream YZ Cubes for Cerec (K022996) Safety and Effectiveness: By definition, a device is substantially equivalent to a predicate devi… | 2002 |
What descends from it? (43)
See all 432 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 25 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K093560 (Shenyang Upcera Co., Ltd., 2010) has gone furthest, with 41 descendants of its own.
- 7 other devices also cite its predicate K062695.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Bisque Zirconia Blanks, Type BYZ are indicated for use as a substructure for ceramic dental restorations.
All blanks are solely by or on the order of a dental professional. They are not for use by the general public or over-the-counter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081850 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081850: Bisque Zirconia Blanks, Type Byz.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081850
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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