510(k) · Cleared
ClearedARENA Star, Galaxy Star
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arum Dentistry Co., Ltd. · EIH Powder, Porcelain
Cleared on Jul 10, 2025 as substantially equivalent to K223253 (Arum Dentistry Co., Ltd., 2023) after a 181-day review. Its family tree reaches back 13 generations to 1983.
- Decided
- Jul 10, 2025
- Review
- 181 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K830955 (1983). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 9 generations between
- 3 generations backK180252 Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded BlankCrown Porcelain Dental Technology Co., Ltd. · 2018
- 2 generations backK190112 Non-Sterile Zirconia BlockFine Advanced Compound Co., Ltd. · 2019
- 1 generation backK223253 Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)Arum Dentistry Co., Ltd. · 2023
- This deviceK250063 ARENA Star, Galaxy StarArum Dentistry Co., Ltd. · 2025
Show all 13 generations
- Root · 13 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 12 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- 11 generations backK984201 DenzirDentronic AB · 1999
- 10 generations backK023327 Cynovad ZirkonCynovad · 2002
- 9 generations backK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- 8 generations backK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- 7 generations backK081850 Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008
- 6 generations backK093560 Upcera Zirconia BlanksShenyang Upcera Co., Ltd. · 2010
- 5 generations backK141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankLiaoning Upcera Co., Ltd. · 2014
- 4 generations backK160367 Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankNissin-Metec China Co., Ltd. · 2016
- 3 generations backK180252 Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded BlankCrown Porcelain Dental Technology Co., Ltd. · 2018
- 2 generations backK190112 Non-Sterile Zirconia BlockFine Advanced Compound Co., Ltd. · 2019
- 1 generation backK223253 Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)Arum Dentistry Co., Ltd. · 2023
- This deviceK250063 ARENA Star, Galaxy StarArum Dentistry Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −12 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| −11 | K984201 | Denzir | Dentronic AB | 1999 | — |
| −10 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| −9 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| −8 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| −7 | K081850 | Bisque Zirconia Blanks, Type Byz | Zircar Zirconia, Inc. | 2008 | — |
| −6 | K093560 | Upcera Zirconia Blanks | Shenyang Upcera Co., Ltd. | 2010 | — |
| −5 | K141724 | Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Liaoning Upcera Co., Ltd. | 2014 | — |
| −4 | K160367 | Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Nissin-Metec China Co., Ltd. | 2016 | — |
| −3 | K180252 | Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank | Crown Porcelain Dental Technology Co., Ltd. | 2018 | — |
| −2 | K190112 | Non-Sterile Zirconia Block | Fine Advanced Compound Co., Ltd. | 2019 | — |
| −1 | K223253 | Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) | Arum Dentistry Co., Ltd. | 2023 | — |
| 0 (this device) | K250063 | ARENA Star, Galaxy Star | Arum Dentistry Co., Ltd. | 2025 | — |
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 |
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 |
|---|---|---|---|
| * | K223253 | Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)Summary page 5…Class II • Date Prepared: 1/10/2025 Predicate Devices The subject device is substantially equivalent to the following predicate devices: Primary Predicate • K223253 Non-Sterile Zirconia Block (ARENA Star, MontBlanc) by Arumdentistry Co., Ltd.… | 2023 |
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 42 years and passes through 12 companies; a new generation was cleared every 2.0 years on median.
- None of the 22 ancestors has a recall.
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?
Non-Sterile Zirconia Block (Model name: ARENA Star, Galaxy Star) are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. All zirconia block are processed through dental laboratories or by dental professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250063 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250063: ARENA Star, Galaxy Star.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250063
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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