510(k) · Cleared
ClearedVariolink Esthetic
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 Nov 25, 2014 as substantially equivalent to K971372 (Ivoclar North America, Inc., 1997) after a 90-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.
- Decided
- Nov 25, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971372 (1997). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK971372 Variolink IIIvoclar North America, Inc. · 1997
- This deviceK142389 Variolink EstheticIvoclar Vivadent, AG · 2014
- Descendant · cites it directly · 0 of its ownK242572 TopCEM-Try in Veneer Try-in GelRizhao Huge Biomaterials Company, Ltd. · 2024
- 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 ownK191389 Allcem Veneer APSDentscare Ltda · 2020
Most influential descendants
Showing 3 of 3 · See all- K242572TopCEM-Try in Veneer Try-in GelRizhao Huge Biomaterials Company, Ltd. · 2024 · cites it directly0descendants
- K241204TopCEM-Veneer Light Cure Veneer CementRizhao Huge Biomaterials Company, Ltd. · 2024 · cites it directly0descendants
- K191389Allcem Veneer APSDentscare Ltda · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971372 | Variolink II | Ivoclar North America, Inc. | 1997 | — |
| 0 (this device) | K142389 | Variolink Esthetic | Ivoclar Vivadent, AG | 2014 | — |
| +1 | K242572 | TopCEM-Try in Veneer Try-in Gel | Rizhao Huge Biomaterials Company, Ltd. | 2024 | — |
| +1 | K241204 | TopCEM-Veneer Light Cure Veneer Cement | Rizhao Huge Biomaterials Company, Ltd. | 2024 | — |
| +1 | K191389 | Allcem Veneer APS | Dentscare Ltda | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K971372 | Variolink IISummary page 4…sification Name: Material, Tooth Shade, Resin (872.3690) (Classification Code EBF) Predicate Device: Variolink II (K971372) Device Description: Variolink® Esthetic is a color-stable adhesive luting system for the… | 1997 |
What descends from it? (3)
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. 2014, 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?
Variolink Esthetic LC: – Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays and veneers) - Only use Variolink Esthetic LC for restorations with a low thickness of <2mm that have sufficient translucency (e.g. restorations made of IPS e.max R HT). Variolink Esthetic DC: – Adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays,partial…
Read the full statement (111 words)
Variolink Esthetic LC:
– Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays and veneers)
- Only use Variolink Esthetic LC for restorations with a low thickness of <2mm that have sufficient translucency (e.g. restorations made of IPS e.max R HT).
Variolink Esthetic DC:
– Adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays,partial crowns, crowns, bridges).
– Restorations made of opaque ceramics, e.g. oxide ceramics, can only be permanently cemented if an adhesive is additionally used that is separately light-cured.
Variolink Esthetic Try-In
To evaluate the overall effect of the restoration in conjunction with the various Variolink Esthetic shades prior to permanent cementation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142389 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142389: Variolink Esthetic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142389
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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