510(k) · Cleared
ClearedErran Dental Zirconia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Erran Technology Co., Ltd. · EIH Powder, Porcelain
Cleared on Dec 13, 2018 as substantially equivalent to K111291 (Qinhuangdao Aidite High-Technical Ceramics Co, Ltd., 2011) after a 134-day review. Its family tree reaches back 9 generations to 1983. 4 later devices descend from it.
- Decided
- Dec 13, 2018
- Review
- 134 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K830955 (1983). 18 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 5 generations between
- 3 generations backK081850 Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008
- 2 generations backK093560 Upcera Zirconia BlanksShenyang Upcera Co., Ltd. · 2010
- 1 generation backK111291 Aidite Zirconia Dental CeramicsQinhuangdao Aidite High-Technical Ceramics Co, Ltd. · 2011
- This deviceK182068 Erran Dental ZirconiaHangzhou Erran Technology Co., Ltd. · 2018
- Descendant · cites it directly · 3 of its ownK192262 Dental Zirconia BlocksDe Corematrix Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK233125 Zirconia BlockHangzhou Ivista Medical Devices Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK221429 KDF Zirconia DiscDenken-Highdental Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK214005 Zirconia Dental CeramicsShenzhen Yurucheng Dental Materials Co., Ltd. · 2022
Show all 9 generations
- Root · 9 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 8 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- 7 generations backK984201 DenzirDentronic AB · 1999
- 6 generations backK023327 Cynovad ZirkonCynovad · 2002
- 5 generations backK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- 4 generations backK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- 3 generations backK081850 Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008
- 2 generations backK093560 Upcera Zirconia BlanksShenyang Upcera Co., Ltd. · 2010
- 1 generation backK111291 Aidite Zirconia Dental CeramicsQinhuangdao Aidite High-Technical Ceramics Co, Ltd. · 2011
- This deviceK182068 Erran Dental ZirconiaHangzhou Erran Technology Co., Ltd. · 2018
Most influential descendants
Showing 4 of 4 · See all- K192262Dental Zirconia BlocksDe Corematrix Co., Ltd. · 2020 · cites it directly3descendants
- K233125Zirconia BlockHangzhou Ivista Medical Devices Co., Ltd. · 2024 · 2 generations on0descendants
- K221429KDF Zirconia DiscDenken-Highdental Co., Ltd. · 2022 · 2 generations on0descendants
- K214005Zirconia Dental CeramicsShenzhen Yurucheng Dental Materials Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −8 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| −7 | K984201 | Denzir | Dentronic AB | 1999 | — |
| −6 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| −5 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| −4 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| −3 | K081850 | Bisque Zirconia Blanks, Type Byz | Zircar Zirconia, Inc. | 2008 | — |
| −2 | K093560 | Upcera Zirconia Blanks | Shenyang Upcera Co., Ltd. | 2010 | — |
| −1 | K111291 | Aidite Zirconia Dental Ceramics | Qinhuangdao Aidite High-Technical Ceramics Co, Ltd. | 2011 | — |
| 0 (this device) | K182068 | Erran Dental Zirconia | Hangzhou Erran Technology Co., Ltd. | 2018 | — |
| +1 | K192262 | Dental Zirconia Blocks | De Corematrix Co., Ltd. | 2020 | — |
| +2 | K233125 | Zirconia Block | Hangzhou Ivista Medical Devices Co., Ltd. | 2024 | — |
| +2 | K221429 | KDF Zirconia Disc | Denken-Highdental Co., Ltd. | 2022 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K111291 | Aidite Zirconia Dental CeramicsSummary page 5…60) Hangzhou Erran Technology Co.,Ltd Proposed Regulatory Class Class II Product Code EIH Predicate Devices Aidite Zirconia Dental Ceramics (K111291) 5. Device Description Normally, Erran Dental Zirconia are offered in blocks and powder and the size as shown below in Table… | 2011 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192262 | Dental Zirconia Blocks | 2020 | 3 |
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 35 years and passes through 9 companies; a new generation was cleared every 2.0 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K192262 (De Corematrix Co., Ltd., 2020) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K111291.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Erran Dental Zirconia are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket
crowns, facing, and veneers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182068: Erran Dental Zirconia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182068
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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