510(k) · Cleared
ClearedVita Cerec Set and Vita Cerec Blocs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vident · ELW Material, Impression
Cleared on Jan 17, 1992 after an 833-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 92 later devices descend from it.
- Decided
- Jan 17, 1992
- Review
- 833 days
- Class
- Class II
- Product code
- ELW
- Recalls
- None
- Predicates
- 0
92 later devices descend from it, 2 citing it directly.
- This deviceK895901 Vita Cerec Set and Vita Cerec BlocsVident · 1992
- Descendant · cites it directly · 91 of its ownK023327 Cynovad ZirkonCynovad · 2002
- Descendant · cites it directly · 80 of its ownK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- Descendant · 2 generations on · 76 of its ownK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- Descendant · 3 generations on · 43 of its ownK081850 Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008
- Descendant · 4 generations on · 41 of its ownK093560 Upcera Zirconia BlanksShenyang Upcera Co., Ltd. · 2010
Showing 5 of 92 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 92 · See all- K023327Cynovad ZirkonCynovad · 2002 · cites it directly91descendants
- K043472Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005 · cites it directly80descendants
- K062695Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006 · 2 generations on76descendants
- K081850Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008 · 3 generations on43descendants
- K093560Upcera Zirconia BlanksShenyang Upcera Co., Ltd. · 2010 · 4 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895901 | Vita Cerec Set and Vita Cerec Blocs | Vident | 1992 | — |
| +1 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| +1 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| +2 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| +3 | K081850 | Bisque Zirconia Blanks, Type Byz | Zircar Zirconia, Inc. | 2008 | — |
| +4 | K093560 | Upcera Zirconia Blanks | Shenyang Upcera Co., Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ELW? 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 ELW device
- #1 K254152 Dia-X Sil Light Bodyscore 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (92)
See all 922 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, K023327 (Cynovad, 2002) has gone furthest, with 91 descendants of its own.
How does its category compare?
All ELW devicesELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ELW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ELW
98in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ELW
3in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ELW
22in 2025
MAUDE reports naming product code ELW, 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 | 7 | 60 | 0 | 9 |
| 2008 | 11 | 30 | 0 | 17 |
| 2009 | 7 | 43 | 0 | 7 |
| 2010 | 5 | 88 | 1 | 16 |
| 2011 | 9 | 83 | 0 | 15 |
| 2012 | 7 | 87 | 1 | 14 |
| 2013 | 5 | 67 | 3 | 32 |
| 2014 | 11 | 122 | 0 | 35 |
| 2015 | 8 | 93 | 0 | 18 |
| 2016 | 7 | 166 | 3 | 15 |
| 2017 | 3 | 89 | 0 | 17 |
| 2018 | 5 | 126 | 0 | 14 |
| 2019 | 2 | — | 0 | 24 |
| 2020 | 4 | 99 | 0 | 8 |
| 2021 | 3 | 76 | 0 | 6 |
| 2022 | 7 | 60 | 0 | 9 |
| 2023 | 2 | — | 0 | 13 |
| 2024 | 3 | 98 | 0 | 3 |
| 2025 | 2 | — | 0 | 22 |
| 2026 | 3 | 268 | 0 | — |
https://510kreport.com/device/K895901 · printed Nov 4, 2026
Cite this page
510(k) Report. “K895901: Vita Cerec Set and Vita Cerec Blocs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K895901
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026