510(k) · Cleared
ClearedAidite Zirconia Dental Ceramics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qinhuangdao Aidite High-Technical Ceramics Co, Ltd. · EIH Powder, Porcelain
Cleared on Jul 20, 2011 as substantially equivalent to K093560 (Shenyang Upcera Co., Ltd., 2010) after a 75-day review. Its family tree reaches back 8 generations to 1983. 7 later devices descend from it.
- Decided
- Jul 20, 2011
- Review
- 75 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. 7 later devices descend from it, 3 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 deviceK111291 Aidite Zirconia Dental CeramicsQinhuangdao Aidite High-Technical Ceramics Co, Ltd. · 2011
- Descendant · cites it directly · 4 of its ownK182068 Erran Dental ZirconiaHangzhou Erran Technology Co., Ltd. · 2018
- Descendant · 2 generations on · 3 of its ownK192262 Dental Zirconia BlocksDe Corematrix Co., Ltd. · 2020
- Descendant · 3 generations on · 0 of its ownK233125 Zirconia BlockHangzhou Ivista Medical Devices Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK221429 KDF Zirconia DiscDenken-Highdental Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK214005 Zirconia Dental CeramicsShenzhen Yurucheng Dental Materials Co., Ltd. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K182068Erran Dental ZirconiaHangzhou Erran Technology Co., Ltd. · 2018 · cites it directly4descendants
- K192262Dental Zirconia BlocksDe Corematrix Co., Ltd. · 2020 · 2 generations on3descendants
- K233125Zirconia BlockHangzhou Ivista Medical Devices Co., Ltd. · 2024 · 3 generations on0descendants
- K221429KDF Zirconia DiscDenken-Highdental Co., Ltd. · 2022 · 3 generations on0descendants
- K214005Zirconia Dental CeramicsShenzhen Yurucheng Dental Materials Co., Ltd. · 2022 · 3 generations on0descendants
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) | K111291 | Aidite Zirconia Dental Ceramics | Qinhuangdao Aidite High-Technical Ceramics Co, Ltd. | 2011 | — |
| +1 | K182068 | Erran Dental Zirconia | Hangzhou Erran Technology Co., Ltd. | 2018 | — |
| +2 | K192262 | Dental Zirconia Blocks | De Corematrix Co., Ltd. | 2020 | — |
| +3 | K233125 | Zirconia Block | Hangzhou Ivista Medical Devices Co., Ltd. | 2024 | — |
| +3 | K221429 | KDF Zirconia Disc | Denken-Highdental Co., Ltd. | 2022 | — |
| +3 | K214005 | Zirconia Dental Ceramics | Shenzhen Yurucheng Dental Materials Co., Ltd. | 2022 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 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 2…are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. Predicate Device Upcera Zirconia Blanks (K093560) Device Description Aidite Zirconia Dental Ceramics are derived from zirconia powder that has been processed via uni-aixial die p… | 2010 |
What descends from it? (7)
3 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 28 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K182068 (Hangzhou Erran Technology Co., Ltd., 2018) has gone furthest, with 4 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. 2011, 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?
Aidite Zirconia Dental Ceramics are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111291 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111291: Aidite Zirconia Dental Ceramics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111291
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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