510(k) · Cleared
ClearedC&B 5.0 Hybrid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arum Dentistry Co., Ltd. · EBG Crown And Bridge, Temporary, Resin
Cleared on Dec 8, 2021 as substantially equivalent to K180657 (Dentis Co., Ltd., 2018) after a 265-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- Dec 8, 2021
- Review
- 265 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K070991 (2007). No later device cites it as a predicate yet.
- Root · 3 generations backK070991 Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102…Vita · 2007
- 2 generations backK102776 Extra-Oral, Additive Computer Aided Manufacture and Curing SystemDeltamed GmbH · 2011
- 1 generation backK180657 Resin for Temporary Crown & BridgeDentis Co., Ltd. · 2018
- This deviceK210817 C&B 5.0 HybridArum Dentistry Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K070991 | Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102, VX59-4110… | Vita | 2007 | — |
| −2 | K102776 | Extra-Oral, Additive Computer Aided Manufacture and Curing System | Deltamed GmbH | 2011 | — |
| −1 | K180657 | Resin for Temporary Crown & Bridge | Dentis Co., Ltd. | 2018 | — |
| 0 (this device) | K210817 | C&B 5.0 Hybrid | Arum Dentistry Co., Ltd. | 2021 | — |
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 EBG? 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 EBG device
- #1 K253380 “FLNT Base” and “FLNT Temp”score 12.4 · 6 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 |
|---|---|---|---|
| * | K180657 | Resin for Temporary Crown & BridgeSummary page 4…ification: Class II, 21 CFR 872.3770 Classification Product Code: EBG 4. Predicate Device: Resin for Temporary Crown & Bridge (K180657) by Dentis Co., Ltd. 1 5. Device Description: The C… | 2018 |
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 14 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K180657.
How does its category compare?
All EBG devicesEBG Crown And Bridge, Temporary, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · EBG
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBG
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBG
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBG
1in 2025
MAUDE reports naming product code EBG, 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 | 3 | 64 | 0 | 4 |
| 2008 | 9 | 83 | 0 | 4 |
| 2009 | 2 | — | 1 | 1 |
| 2010 | 5 | 103 | 0 | 1 |
| 2011 | 10 | 96 | 0 | 1 |
| 2012 | 5 | 90 | 0 | 5 |
| 2013 | 2 | — | 0 | 11 |
| 2014 | 3 | 114 | 0 | 23 |
| 2015 | 6 | 209 | 0 | 26 |
| 2016 | 4 | 163 | 0 | 8 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 4 | 202 | 0 | 0 |
| 2019 | 6 | 98 | 0 | 6 |
| 2020 | 14 | 194 | 1 | 2 |
| 2021 | 3 | 265 | 0 | 4 |
| 2022 | 3 | 73 | 0 | 2 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 5 | 144 | 0 | 0 |
| 2025 | 4 | 106 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
C&B 5.0 Hybrid resin is a light-curable polymerizable resin to fabricate, by additive manufacturing, temporary crowns or bridges. The fabricated temporary crowns or bridges are an alternative to preformed temporary crowns or bridges and require digital models of crowns or bridges, a stereolithographic additive printer, and curing light equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210817 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210817: C&B 5.0 Hybrid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210817
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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