510(k) · Cleared
ClearedMultilink Automix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, AG · EBF Material, Tooth Shade, Resin
Cleared on Jan 31, 2013 as substantially equivalent to K032470 (Ivoclar Vivadent, Inc., 2003) after an 87-day review. Its family tree reaches back 1 generation to 2003. 5 later devices descend from it.
- Decided
- Jan 31, 2013
- Review
- 87 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032470 (2003). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK032470 MultilinkIvoclar Vivadent, Inc. · 2003
- This deviceK123397 Multilink AutomixIvoclar Vivadent, AG · 2013
- Descendant · cites it directly · 2 of its ownK201790 Dual Cure Resin CementRizhao Huge Biomaterials Company, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK241204 TopCEM-Veneer Light Cure Veneer CementRizhao Huge Biomaterials Company, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK233082 TopCEM Dual Cure Resin CementRizhao Huge Biomaterials Company, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK191527 Visalys CemCore, Visalys Cem Core Try In PasteKettenbach GmbH & Co. KG · 2019
- Descendant · cites it directly · 0 of its ownK162677 L- OVCRhondium, Ltd. · 2016
Most influential descendants
Showing 5 of 5 · See all- K201790Dual Cure Resin CementRizhao Huge Biomaterials Company, Ltd. · 2020 · cites it directly2descendants
- K241204TopCEM-Veneer Light Cure Veneer CementRizhao Huge Biomaterials Company, Ltd. · 2024 · 2 generations on0descendants
- K233082TopCEM Dual Cure Resin CementRizhao Huge Biomaterials Company, Ltd. · 2023 · 2 generations on0descendants
- K191527Visalys CemCore, Visalys Cem Core Try In PasteKettenbach GmbH & Co. KG · 2019 · cites it directly0descendants
- K162677L- OVCRhondium, Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032470 | Multilink | Ivoclar Vivadent, Inc. | 2003 | — |
| 0 (this device) | K123397 | Multilink Automix | Ivoclar Vivadent, AG | 2013 | — |
| +1 | K201790 | Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2020 | — |
| +2 | K241204 | TopCEM-Veneer Light Cure Veneer Cement | Rizhao Huge Biomaterials Company, Ltd. | 2024 | — |
| +2 | K233082 | TopCEM Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | 2023 | — |
| +1 | K191527 | Visalys CemCore, Visalys Cem Core Try In Paste | Kettenbach GmbH & Co. KG | 2019 | — |
| +1 | K162677 | L- OVC | Rhondium, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K032470 | MultilinkSummary page 1…er 4, 2012 Proprietary Name: Multilink Automix Classification Name: Material, Tooth Shade, Resin (872.3690) Predicate Devices: Multilink (K032470) Device Description: Multilink Automix is a self-curing and self-etching luting composite system for the adhesive luting… | 2003 |
What descends from it? (5)
3 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?
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Multilink Automix Is used for the permanent cementation of Indirect restorations where a strong bond is desired: Inlays, onlays, crowns, bridges and root posts made of:
Metal and metal ceramics
All-ceramics, In particular opaque zirconium oxide ceramics
Composites and fibre-reinforced composites
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123397 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123397: Multilink Automix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123397
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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