510(k) · Cleared
ClearedDental Glass Ceramics Blocks
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aidite (Qinhuangdao) Technology Co., Ltd. · EIH Powder, Porcelain
Cleared on Jul 8, 2020 as substantially equivalent to K141727 (Liaoning Upcera Co., Ltd., 2014) after a 327-day review. Its family tree reaches back 3 generations to 2007. 5 later devices descend from it.
- Decided
- Jul 8, 2020
- Review
- 327 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K070772 (2007). 4 ancestors in all. 5 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK070772 Pressx ZRWieland Dental + Technik GmbH & Co. KG · 2007
- 2 generations backK123952 Cerec Blocs C inSirona Dental Systems GmbH · 2013
- 1 generation backK141727 Dental Lithium Disilicate Glass Ceramic Block (UP. Press Series and…Liaoning Upcera Co., Ltd. · 2014
- This deviceK192231 Dental Glass Ceramics BlocksAidite (Qinhuangdao) Technology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK242407 Dental Glass Ceramics Blocks (HT, LT, MT)Hunan Vsmile Biotechnology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK241715 Dental Glass Ceramics Blocks (HT,LT,ST)Aidite (Qinhuangdao) Technology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK232438 Dental Glass Ceramics BlocksAibodent Biotechnology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK230259 Soreal Press, Soreal CADShenzhen Up3D Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK222513 Glass CeramicsYilink (Tianjin) Biotechnology Co., Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K242407Dental Glass Ceramics Blocks (HT, LT, MT)Hunan Vsmile Biotechnology Co., Ltd. · 2024 · cites it directly0descendants
- K241715Dental Glass Ceramics Blocks (HT,LT,ST)Aidite (Qinhuangdao) Technology Co., Ltd. · 2024 · cites it directly0descendants
- K232438Dental Glass Ceramics BlocksAibodent Biotechnology Co., Ltd. · 2023 · cites it directly0descendants
- K230259Soreal Press, Soreal CADShenzhen Up3D Technology Co., Ltd. · 2023 · cites it directly0descendants
- K222513Glass CeramicsYilink (Tianjin) Biotechnology Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K070772 | Pressx ZR | Wieland Dental + Technik GmbH & Co. KG | 2007 | — |
| −2 | K123952 | Cerec Blocs C in | Sirona Dental Systems GmbH | 2013 | — |
| −1 | K141727 | Dental Lithium Disilicate Glass Ceramic Block (UP. Press Series and UP. Cad… | Liaoning Upcera Co., Ltd. | 2014 | — |
| 0 (this device) | K192231 | Dental Glass Ceramics Blocks | Aidite (Qinhuangdao) Technology Co., Ltd. | 2020 | — |
| +1 | K242407 | Dental Glass Ceramics Blocks (HT, LT, MT) | Hunan Vsmile Biotechnology Co., Ltd. | 2024 | — |
| +1 | K241715 | Dental Glass Ceramics Blocks (HT,LT,ST) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2024 | — |
| +1 | K232438 | Dental Glass Ceramics Blocks | Aibodent Biotechnology Co., Ltd. | 2023 | — |
| +1 | K230259 | Soreal Press, Soreal CAD | Shenzhen Up3D Technology Co., Ltd. | 2023 | — |
| +1 | K222513 | Glass Ceramics | Yilink (Tianjin) Biotechnology Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 0 |
| 2024 | 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 K262074 Any-Zircosscore 14.9 · 11 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 |
|---|---|---|---|
| * | K141727 | Dental Lithium Disilicate Glass Ceramic Block (UP. Press Series and UP. Cad Series)Summary page 4…Trade Name Dental Lithium Disilicate Glass Ceramic Block( Up.Press Series and Up. CAD Series) 510(k) Number K141727 Product Code EIH Manufacturer Liaoning Upcera Co., Ltd 4. Device Description D… | 2014 |
What descends from it? (5)
5 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 13 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K242407 (Hunan Vsmile Biotechnology Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K141727.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Glass Ceramics Blocks are indicated for fabricating all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192231: Dental Glass Ceramics Blocks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192231
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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