510(k) · Cleared
ClearedCERABIEN MiLai
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray Noritake Dental, Inc. · EIH Powder, Porcelain
Cleared on May 29, 2025 as substantially equivalent to K213147 (Kuraray Noritake Dental, Inc., 2022) and 2 other predicates after an 84-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.
- Decided
- May 29, 2025
- Review
- 84 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K043462 (2005). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K262195Dandy Ceramic Stain and GlazeZima International Inc., dba Dandy · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K043462 | CZR Press LF | Noritake Co., Inc. | 2005 | — |
| 0 (this device) | K250673 | CERABIEN MiLai | Kuraray Noritake Dental, Inc. | 2025 | — |
| +1 | K262195 | Dandy Ceramic Stain and Glaze | Zima International Inc., dba Dandy | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K213147 | CERABIEN MiLaiSummary page 5…rcelain powder for clinical use Powder, Porcelain 872.6660 EIH 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K213147 CERABIEN MilLai EIH K043462 CZR PRESS LF EIH K170834 CERABIEN ZR EIH Device Description Summary 21 CFR 807.92(a)(4) (1 i2AECiD… | 2022 |
| * | K043462 | CZR Press LFSummary page 5…use Powder, Porcelain 872.6660 EIH 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K213147 CERABIEN MilLai EIH K043462 CZR PRESS LF EIH K170834 CERABIEN ZR EIH Device Description Summary 21 CFR 807.92(a)(4) (1 i2AECiD) CERABIEN MiLai is a speci… | 2005 |
| * | K170834 | Cerabien ZRSummary page 5…72.6660 EIH 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K213147 CERABIEN MilLai EIH K043462 CZR PRESS LF EIH K170834 CERABIEN ZR EIH Device Description Summary 21 CFR 807.92(a)(4) (1 i2AECiD) CERABIEN MiLai is a specific type of porcelain for… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262195 | Dandy Ceramic Stain and Glaze | 2026 | 0 |
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K262195 (Zima International Inc., dba Dandy, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
For use in prosthetic dentistry to create an all-ceramic prosthesis.
- Ceramic for coverage of a zirconia substructure
- Ceramic for coverage of a lithium disilicate substructure
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K250673 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250673: CERABIEN MiLai.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250673
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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