510(k) · Cleared
ClearedMultilink
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, Inc. · EMA Cement, Dental
Cleared on Nov 5, 2003 after an 86-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Nov 5, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK032470 MultilinkIvoclar Vivadent, Inc. · 2003
- Descendant · cites it directly · 5 of its ownK123397 Multilink AutomixIvoclar Vivadent, AG · 2013
- Descendant · 2 generations on · 2 of its ownK201790 Dual Cure Resin CementRizhao Huge Biomaterials Company, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK121804 Provitemp, Dentotemp, Totalcem, DentocemItena Clinical · 2013
- Descendant · 3 generations on · 0 of its ownK241204 TopCEM-Veneer Light Cure Veneer CementRizhao Huge Biomaterials Company, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK233082 TopCEM Dual Cure Resin CementRizhao Huge Biomaterials Company, Ltd. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K123397Multilink AutomixIvoclar Vivadent, AG · 2013 · cites it directly5descendants
- K201790Dual Cure Resin CementRizhao Huge Biomaterials Company, Ltd. · 2020 · 2 generations on2descendants
- K121804Provitemp, Dentotemp, Totalcem, DentocemItena Clinical · 2013 · cites it directly1descendant
- K241204TopCEM-Veneer Light Cure Veneer CementRizhao Huge Biomaterials Company, Ltd. · 2024 · 3 generations on0descendants
- K233082TopCEM Dual Cure Resin CementRizhao Huge Biomaterials Company, Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032470 | Multilink | Ivoclar Vivadent, Inc. | 2003 | — |
| +1 | K123397 | Multilink Automix | Ivoclar Vivadent, AG | 2013 | — |
| +2 | K201790 | Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2020 | — |
| +1 | K121804 | Provitemp, Dentotemp, Totalcem, Dentocem | Itena Clinical | 2013 | — |
| +3 | K241204 | TopCEM-Veneer Light Cure Veneer Cement | Rizhao Huge Biomaterials Company, Ltd. | 2024 | — |
| +3 | K233082 | TopCEM Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
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?
- Of its descendants, K123397 (Ivoclar Vivadent, AG, 2013) has gone furthest, with 5 descendants of its own.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Multilink® is a self-curing and self-etching luting composite system for the adhesive luting of indirect restorations made of metal, metal-ceramic, all-ceramic and composite.
It is contraindicated if the patient has allergies to any ingredient; and no direct application on pulpa-near dentin or on the open pulp or irritations of the pulp may occur.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032470 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032470: Multilink.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032470
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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