510(k) · Cleared
ClearedTopCEM Dual Cure Resin Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rizhao Huge Biomaterials Company, Ltd. · EBF Material, Tooth Shade, Resin
Cleared on Dec 22, 2023 as substantially equivalent to K052820 (Coltene/Whaledent AG, 2006) and 1 other predicate after an 87-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Dec 22, 2023
- Review
- 87 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K032470 (2003). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK032470 MultilinkIvoclar Vivadent, Inc. · 2003
- 2 generations backK123397 Multilink AutomixIvoclar Vivadent, AG · 2013
- 1 generation backK201790 Dual Cure Resin CementRizhao Huge Biomaterials Company, Ltd. · 2020
- This deviceK233082 TopCEM Dual Cure Resin CementRizhao Huge Biomaterials Company, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K032470 | Multilink | Ivoclar Vivadent, Inc. | 2003 | — |
| −2 | K123397 | Multilink Automix | Ivoclar Vivadent, AG | 2013 | — |
| −1 | K201790 | Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2020 | — |
| 0 (this device) | K233082 | TopCEM Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (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 |
|---|---|---|---|
| * | K052820 | Parapost Paracore Automix 5MLSummary page 5…vice Trade Name 510 (k) No. Product Code Predicate COLTENE/WHALEDENT PARAPOST PARACORE K052820 EBF Primary AG AUTOMIX 5ML Rizhao HuGe Biomaterials… | 2006 |
| * | K201790 | Dual Cure Resin CementSummary page 5…52820 EBF Primary AG AUTOMIX 5ML Rizhao HuGe Biomaterials Dual Cure Resin Cement K201790 EMA, EBF Secondary Company, Ltd. These predicate devices have not been subject to a design-related rec… | 2020 |
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 20 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
- Permanent cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers and other restorations made from materials of metals/alloys, metal-ceramic, all-ceramic and/or porcelain, composites, and their combinations.
- Permanent cementation for all types of root canal posts.
- Core build-ups.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233082 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233082: TopCEM Dual Cure Resin Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233082
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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