510(k) · Cleared
ClearedVariolink II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar North America, Inc. · EBF Material, Tooth Shade, Resin
Cleared on May 29, 1997 after a 45-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- May 29, 1997
- Review
- 45 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 4 citing it directly.
- This deviceK971372 Variolink IIIvoclar North America, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK142389 Variolink EstheticIvoclar Vivadent, AG · 2014
- Descendant · 2 generations on · 0 of its ownK242572 TopCEM-Try in Veneer Try-in GelRizhao Huge Biomaterials Company, Ltd. · 2024
- 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 ownK191389 Allcem Veneer APSDentscare Ltda · 2020
- Descendant · cites it directly · 0 of its ownK141503 Denali 501CEMENTDenali Corporation · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K142389Variolink EstheticIvoclar Vivadent, AG · 2014 · cites it directly3descendants
- K242572TopCEM-Try in Veneer Try-in GelRizhao Huge Biomaterials Company, Ltd. · 2024 · 2 generations on0descendants
- K241204TopCEM-Veneer Light Cure Veneer CementRizhao Huge Biomaterials Company, Ltd. · 2024 · 2 generations on0descendants
- K191389Allcem Veneer APSDentscare Ltda · 2020 · 2 generations on0descendants
- K141503Denali 501CEMENTDenali Corporation · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971372 | Variolink II | Ivoclar North America, Inc. | 1997 | — |
| +1 | K142389 | Variolink Esthetic | Ivoclar Vivadent, AG | 2014 | — |
| +2 | K242572 | TopCEM-Try in Veneer Try-in Gel | Rizhao Huge Biomaterials Company, Ltd. | 2024 | — |
| +2 | K241204 | TopCEM-Veneer Light Cure Veneer Cement | Rizhao Huge Biomaterials Company, Ltd. | 2024 | — |
| +2 | K191389 | Allcem Veneer APS | Dentscare Ltda | 2020 | — |
| +1 | K141503 | Denali 501CEMENT | Denali Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2014 | 2 | 0 |
| 2020 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
4 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, K142389 (Ivoclar Vivadent, AG, 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K971372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971372: Variolink II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971372
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026