510(k) · Cleared
ClearedUpcera Dental Zirconia Blank for Aesthetic Restoration
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Liaoning Upcera Co., Ltd. · EIH Powder, Porcelain
Cleared on Dec 4, 2015 as substantially equivalent to K093560 (Shenyang Upcera Co., Ltd., 2010) after a 122-day review. Its family tree reaches back 8 generations to 1983. 4 later devices descend from it.
- Decided
- Dec 4, 2015
- Review
- 122 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K830955 (1983). 17 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 7 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- 6 generations backK984201 DenzirDentronic AB · 1999
- 5 generations backK023327 Cynovad ZirkonCynovad · 2002
- 4 generations backK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- 3 generations backK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- 2 generations backK081850 Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008
- 1 generation backK093560 Upcera Zirconia BlanksShenyang Upcera Co., Ltd. · 2010
- This deviceK152175 Upcera Dental Zirconia Blank for Aesthetic RestorationLiaoning Upcera Co., Ltd. · 2015
- Descendant · cites it directly · 2 of its ownK231687 Gradual Dental Zirconia BlankLiaoning Upcera Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK253973 Gradual Dental Zirconia Blank - GT (F) P1, GT (F) P2, and SP SeriesLiaoning Upcera Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251593 DenMat Multilayered Zirconia DiscDenmat Holding, LLC · 2025
- Descendant · cites it directly · 0 of its ownK240912 Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)Anhui Miisen Intelligence Technology Co., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K231687Gradual Dental Zirconia BlankLiaoning Upcera Co., Ltd. · 2023 · cites it directly2descendants
- K253973Gradual Dental Zirconia Blank - GT (F) P1, GT (F) P2, and SP SeriesLiaoning Upcera Co., Ltd. · 2026 · 2 generations on0descendants
- K251593DenMat Multilayered Zirconia DiscDenmat Holding, LLC · 2025 · 2 generations on0descendants
- K240912Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)Anhui Miisen Intelligence Technology Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −7 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| −6 | K984201 | Denzir | Dentronic AB | 1999 | — |
| −5 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| −4 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| −3 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| −2 | K081850 | Bisque Zirconia Blanks, Type Byz | Zircar Zirconia, Inc. | 2008 | — |
| −1 | K093560 | Upcera Zirconia Blanks | Shenyang Upcera Co., Ltd. | 2010 | — |
| 0 (this device) | K152175 | Upcera Dental Zirconia Blank for Aesthetic Restoration | Liaoning Upcera Co., Ltd. | 2015 | — |
| +1 | K231687 | Gradual Dental Zirconia Blank | Liaoning Upcera Co., Ltd. | 2023 | — |
| +2 | K253973 | Gradual Dental Zirconia Blank - GT (F) P1, GT (F) P2, and SP Series | Liaoning Upcera Co., Ltd. | 2026 | — |
| +2 | K251593 | DenMat Multilayered Zirconia Disc | Denmat Holding, LLC | 2025 | — |
| +1 | K240912 | Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) | Anhui Miisen Intelligence Technology Co., Ltd. | 2024 | — |
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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K093560 | Upcera Zirconia BlanksSummary page 4…II Regulation Number: 21 CFR 872.6660 Panel: General Dental Product Code: EIH Predicate Device Information: K093560, “Upcera Zirconia Blanks”, manufactured by “Shenyang Upcera Co., Ltd.” Device Description: “Dental Zirconia Blank… | 2010 |
What descends from it? (4)
2 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 32 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K231687 (Liaoning Upcera Co., Ltd., 2023) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K093560.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
“Dental Zirconia Blank for Aesthetic Restoration” is mainly used in prosthetic treatment. When the flexural strength of Dental Zirconia Blank for Aesthetic Restoration after sintering is between 300-500 MPa, the product can be used for veneering, inlay, single crown, and substructure ceramic for three-unit prostheses not involving molar restoration; when the flexural strength of Dental Zirconia Blank for Aesthetic Restoration after sintering is over 500 MPa, it can be used for veneering, inlay, single crown, and substrate ceramic for three-unit prostheses. All blanks are processed through dental laboratories or by dental professionals.”
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152175: Upcera Dental Zirconia Blank for Aesthetic Restoration.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152175
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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