510(k) · Cleared

Cleared

Variolink

K931309510(k) TraditionalCleared Jul 22, 1993129-day reviewClass II21 CFR 872.3690

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ivoclar North America, Inc. · EBF Material, Tooth Shade, Resin

Cleared on Jul 22, 1993 after a 129-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 14 later devices descend from it.

Decided: Jul 22, 1993
Review: 129 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 0

14 later devices descend from it, 4 citing it directly.

This deviceK931309 VariolinkIvoclar North America, Inc. · 1993
Descendant · cites it directly · 5 of its ownK153231 G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc. · 2016
Descendant · cites it directly · 5 of its ownK012316 Permacem / Permacem DualDmg USA, Inc. · 2001
Descendant · 2 generations on · 3 of its ownK200798 G-Cem OneGC America, Inc. · 2020
Descendant · 2 generations on · 1 of its ownK121804 Provitemp, Dentotemp, Totalcem, DentocemItena Clinical · 2013
Descendant · 2 generations on · 1 of its ownK041960 Composite/Compomer Repair KitDmg USA, Inc. · 2004

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

1998high 3 (2025) · low 0 (1999)2026

Most influential descendants

Showing 5 of 14 · See all

K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc. · 2016 · cites it directly5descendants
K012316Permacem / Permacem DualDmg USA, Inc. · 2001 · cites it directly5descendants
K200798G-Cem OneGC America, Inc. · 2020 · 2 generations on3descendants
K121804Provitemp, Dentotemp, Totalcem, DentocemItena Clinical · 2013 · 2 generations on1descendant
K041960Composite/Compomer Repair KitDmg USA, Inc. · 2004 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K931309	Variolink	Ivoclar North America, Inc.	1993	—
+1	K153231	G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer	GC America, Inc.	2016	—
+1	K012316	Permacem / Permacem Dual	Dmg USA, Inc.	2001	—
+2	K200798	G-Cem One	GC America, Inc.	2020	—
+2	K121804	Provitemp, Dentotemp, Totalcem, Dentocem	Itena Clinical	2013	—
+2	K041960	Composite/Compomer Repair Kit	Dmg USA, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2001	1	0
2003	1	0
2004	1	0
2007	1	0
2011	1	0
2013	1	0
2016	1	0
2017	1	0
2020	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K931309, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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? (14)

See all 14

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K153231	G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer	GC America, Inc.	2016	5
K012316	Permacem / Permacem Dual	Dmg USA, Inc.	2001	5
K111836	Permashade Veneer Cement	Ultradent Products, Inc.	2011	0
K982895	Sternomega Compomer Cement	Sterngold/Implamed	1998	0

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, K153231 (GC America, Inc., 2016) has gone furthest, with 5 descendants of its own.

How does its category compare?

All EBF devices

EBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBF

15in 2025

2007high 20 (2009) · low 9 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBF

43in 2025

2007high 205 (2016) · low 43 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EBF

1in 2020

2007high 42 (2008) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EBF

1in 2025

2007high 246 (2013) · low 1 (2025)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/K931309 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931309: Variolink.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931309

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026