510(k) · Cleared
ClearedGlass Ceramics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yilink (Tianjin) Biotechnology Co., Ltd. · EIH Powder, Porcelain
Cleared on Feb 10, 2023 as substantially equivalent to K192231 (Aidite (Qinhuangdao) Technology Co., Ltd., 2020) after a 175-day review. Its family tree reaches back 4 generations to 2007.
- Decided
- Feb 10, 2023
- Review
- 175 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K070772 (2007). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK070772 Pressx ZRWieland Dental + Technik GmbH & Co. KG · 2007
- 3 generations backK123952 Cerec Blocs C inSirona Dental Systems GmbH · 2013
- 2 generations backK141727 Dental Lithium Disilicate Glass Ceramic Block (UP. Press Series and…Liaoning Upcera Co., Ltd. · 2014
- 1 generation backK192231 Dental Glass Ceramics BlocksAidite (Qinhuangdao) Technology Co., Ltd. · 2020
- This deviceK222513 Glass CeramicsYilink (Tianjin) Biotechnology Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K070772 | Pressx ZR | Wieland Dental + Technik GmbH & Co. KG | 2007 | — |
| −3 | K123952 | Cerec Blocs C in | Sirona Dental Systems GmbH | 2013 | — |
| −2 | K141727 | Dental Lithium Disilicate Glass Ceramic Block (UP. Press Series and UP. Cad… | Liaoning Upcera Co., Ltd. | 2014 | — |
| −1 | K192231 | Dental Glass Ceramics Blocks | Aidite (Qinhuangdao) Technology Co., Ltd. | 2020 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K192231 | Dental Glass Ceramics BlocksSummary page 5…Name 510 (k) No. Product Code Predicate Aidite (Qinhuangdao) Dental Glass Ceramics Blocks K192231 EIH Primary Technology Co., Ltd. This predicate device has not been subject to a design-r… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- None of the 5 ancestors has a recall.
- 4 other devices also cite its predicate K192231.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Glass Ceramics 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/K222513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222513: Glass Ceramics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222513
Report an extraction error
Are you the manufacturer?
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