510(k) · Cleared
ClearedNanoCeram Resin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3BFAB Teknoloji a.S. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Jul 31, 2026 as substantially equivalent to K240688 (Belport Company, Inc., Gingi-Pak, 2024) and 1 other predicate after a 1-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Jul 31, 2026
- Review
- 1 day
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K901789 (1990). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK901789 Paladon (R) 65Kulzer, Inc. · 1990
- 7 generations backK081884 Major.Base 20Major Prodotti Dentari S.P.A. · 2008
- 6 generations backK102654 Vertex Rapid SimplifiedVertex-Dental B.V. · 2010
- 5 generations backK130076 Promolux, Promolux HI, Weropress, Premeco PCSMerz Dental GmbH · 2013
- 4 generations backK140758 M-PM-Disc (Pink)Merz Dental GmbH · 2014
- 3 generations backK151142 Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling…Wieland Dental + Technik GmbH & Co. KG · 2015
- 2 generations backK230445 OnX ToughSprintray, Inc. · 2023
- 1 generation backK240688 RODIN Titan 3D ResinBelport Company, Inc., Gingi-Pak · 2024
- This deviceK262681 NanoCeram Resin3BFAB Teknoloji a.S. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K901789 | Paladon (R) 65 | Kulzer, Inc. | 1990 | — |
| −7 | K081884 | Major.Base 20 | Major Prodotti Dentari S.P.A. | 2008 | — |
| −6 | K102654 | Vertex Rapid Simplified | Vertex-Dental B.V. | 2010 | — |
| −5 | K130076 | Promolux, Promolux HI, Weropress, Premeco PCS | Merz Dental GmbH | 2013 | — |
| −4 | K140758 | M-PM-Disc (Pink) | Merz Dental GmbH | 2014 | — |
| −3 | K151142 | Ivobase Cad for Zenotec, Ivobase Cad Bond, Ivobase Cad Modelling Liquid | Wieland Dental + Technik GmbH & Co. KG | 2015 | — |
| −2 | K230445 | OnX Tough | Sprintray, Inc. | 2023 | — |
| −1 | K240688 | RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak | 2024 | — |
| 0 (this device) | K262681 | NanoCeram Resin | 3BFAB Teknoloji a.S. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 EBI? 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 EBI device
- #1 K250617 Apex Flexscore 18.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K240688 | RODIN Titan 3D ResinSummary page 5…0 Product Code(s) EBI, EBF, PZY Legally Marketed Predicate Devices Predicate K# Trade Name Product Code K240688 RODIN Titan 3D Resin EBI, EBF K230445 OnX Tough EBI… | 2024 |
| * | K230445 | OnX ToughSummary page 5…redicate Devices Predicate K# Trade Name Product Code K240688 RODIN Titan 3D Resin EBI, EBF K230445 OnX Tough EBI, PZY Device Description Summary NanoCeram Resin is a light-curable, c… | 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 36 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- None of the 20 ancestors has a recall.
How does its category compare?
All EBI devicesEBI Resin, Denture, Relining, Repairing, Rebasing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · EBI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBI
79in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBI
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBI
34in 2025
MAUDE reports naming product code EBI, 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 | 10 | 53 | 0 | 7 |
| 2008 | 6 | 124 | 0 | 2 |
| 2009 | 3 | 234 | 0 | 5 |
| 2010 | 4 | 95 | 0 | 4 |
| 2011 | 11 | 113 | 0 | 6 |
| 2012 | 3 | 85 | 0 | 9 |
| 2013 | 5 | 135 | 0 | 5 |
| 2014 | 5 | 102 | 0 | 9 |
| 2015 | 9 | 106 | 0 | 8 |
| 2016 | 7 | 147 | 0 | 9 |
| 2017 | 8 | 196 | 0 | 2 |
| 2018 | 5 | 158 | 2 | 2 |
| 2019 | 4 | 127 | 0 | 10 |
| 2020 | 6 | 283 | 0 | 8 |
| 2021 | 4 | 99 | 0 | 25 |
| 2022 | 11 | 154 | 2 | 2 |
| 2023 | 11 | 96 | 0 | 13 |
| 2024 | 9 | 90 | 0 | 1 |
| 2025 | 11 | 79 | 0 | 34 |
| 2026 | 7 | 87 | 0 | — |
What is it indicated for?
NanoCeram Resin is a light-curing 3D printed material designed as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. NanoCeram Resin material is used in the fabrication of permanent restorations such as inlays, onlays, veneers and full crown restorations. NanoCeram Resin is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant supported denture prosthetics, monolithic full and partial removable denture and preformed denture teeth to be used in a denture.
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/K262681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262681: NanoCeram Resin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262681
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026