510(k) · Cleared
ClearedAMBARINO High-Class
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Creamed GmbH & Co. Produktions- Und Handels KG · EBF Material, Tooth Shade, Resin
Cleared on Sep 9, 2022 as substantially equivalent to K130841 (Shofu Dental Corporation, 2013) after a 1-day review. Its family tree reaches back 1 generation to 2013. 2 later devices descend from it.
- Decided
- Sep 9, 2022
- Review
- 1 day
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K130841 (2013). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK130841 Shofu Block HCShofu Dental Corporation · 2013
- This deviceK222723 AMBARINO High-ClassCreamed GmbH & Co. Produktions- Und Handels KG · 2022
- Descendant · cites it directly · 0 of its ownK261357 Grandio disc multicolorVoco GmbH · 2026
- Descendant · cites it directly · 0 of its ownK223742 Dental Ceramic BlocksAidite (Qinhuangdao) Technology Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K130841 | Shofu Block HC | Shofu Dental Corporation | 2013 | — |
| 0 (this device) | K222723 | AMBARINO High-Class | Creamed GmbH & Co. Produktions- Und Handels KG | 2022 | — |
| +1 | K261357 | Grandio disc multicolor | Voco GmbH | 2026 | — |
| +1 | K223742 | Dental Ceramic Blocks | Aidite (Qinhuangdao) Technology Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 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 EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 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 |
|---|---|---|---|
| * | K130841 | Shofu Block HCSummary page 4…872.3690 Product Code: EBF Class: Class II Classification Panel: Dental Legally Marketed Predicate Device: ● Shofu Block HC (K130841); Manufacturer: SHOFU DENTAL Device Description: The AMBARINO® High-Class CAD/CAM formed materials consist of interpenetrating n… | 2013 |
What descends from it? (2)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K261357 (Voco GmbH, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
AMBARINO® High-Class is indicated for fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental professionals and manufacturers using a dental CAD/CAM system.
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/K222723 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222723: AMBARINO High-Class.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222723
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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