510(k) · Cleared
ClearedDual 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. · EMA Cement, Dental
Cleared on Sep 29, 2020 as substantially equivalent to K123397 (Ivoclar Vivadent, AG, 2013) after a 91-day review. Its family tree reaches back 2 generations to 2003. 2 later devices descend from it.
- Decided
- Sep 29, 2020
- Review
- 91 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032470 (2003). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK032470 MultilinkIvoclar Vivadent, Inc. · 2003
- 1 generation backK123397 Multilink AutomixIvoclar Vivadent, AG · 2013
- This deviceK201790 Dual Cure Resin CementRizhao Huge Biomaterials Company, Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK241204 TopCEM-Veneer Light Cure Veneer CementRizhao Huge Biomaterials Company, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK233082 TopCEM Dual Cure Resin CementRizhao Huge Biomaterials Company, 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 |
|---|---|---|---|---|---|
| −2 | K032470 | Multilink | Ivoclar Vivadent, Inc. | 2003 | — |
| −1 | K123397 | Multilink Automix | Ivoclar Vivadent, AG | 2013 | — |
| 0 (this device) | K201790 | Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2020 | — |
| +1 | K241204 | TopCEM-Veneer Light Cure Veneer Cement | Rizhao Huge Biomaterials Company, Ltd. | 2024 | — |
| +1 | K233082 | TopCEM Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 EMA? 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 EMA device
- #1 K254109 G-Cem Universalscore 15.0 · 13 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 |
|---|---|---|---|
| * | K123397 | Multilink AutomixSummary page 4…Information Owner/Operator Device Trade Name 510 (k) No. Product Code Predicate IVOCLAR VIVADENT AG Multilink Automix K123397 EBF Primary This predicate device has not been subject to a design-related recall. No reference devices… | 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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K241204 (Rizhao Huge Biomaterials Company, Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K123397.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · EMA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EMA
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EMA
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMA
9in 2025
MAUDE reports naming product code EMA, 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 | 6 | 48 | 0 | 33 |
| 2008 | 13 | 71 | 2 | 50 |
| 2009 | 10 | 86 | 1 | 90 |
| 2010 | 14 | 86 | 1 | 106 |
| 2011 | 8 | 79 | 5 | 224 |
| 2012 | 10 | 128 | 0 | 249 |
| 2013 | 12 | 178 | 0 | 385 |
| 2014 | 4 | 174 | 0 | 207 |
| 2015 | 9 | 134 | 0 | 85 |
| 2016 | 10 | 182 | 0 | 16 |
| 2017 | 3 | 141 | 0 | 13 |
| 2018 | 3 | 237 | 0 | 4 |
| 2019 | 7 | 127 | 0 | 12 |
| 2020 | 8 | 164 | 0 | 5 |
| 2021 | 4 | 184 | 0 | 8 |
| 2022 | 7 | 245 | 0 | 3 |
| 2023 | 2 | — | 1 | 6 |
| 2024 | 3 | 59 | 0 | 5 |
| 2025 | 10 | 106 | 0 | 9 |
| 2026 | 7 | 150 | 0 | — |
What is it indicated for?
Dual Cure Resin Cement is a dental luting system designed for cementation of all sorts of dental restorations including
crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metal-
ceramic, all-ceramic and/or porcelain, composites, and their combinations.
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/K201790 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201790: Dual Cure Resin Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201790
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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