510(k) · Cleared

Cleared

Ips Empress Direct Flow

K103528510(k) TraditionalCleared Feb 25, 201187-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 Vivadent, Inc. · EBF Material, Tooth Shade, Resin

Cleared on Feb 25, 2011 after an 87-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: Feb 25, 2011
Review: 87 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK103528 Ips Empress Direct FlowIvoclar Vivadent, Inc. · 2011
Descendant · cites it directly · 1 of its ownK122521 Prevent SealItena Clinical · 2013
Descendant · 2 generations on · 0 of its ownK141717 Pacseal Pit & Fissure SealantPac-Dent International, Inc. · 2015

Most influential descendants

Showing 2 of 2 · See all

K122521Prevent SealItena Clinical · 2013 · cites it directly1descendant
K141717Pacseal Pit & Fissure SealantPac-Dent International, Inc. · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K103528	Ips Empress Direct Flow	Ivoclar Vivadent, Inc.	2011	—
+1	K122521	Prevent Seal	Itena Clinical	2013	—
+2	K141717	Pacseal Pit & Fissure Sealant	Pac-Dent International, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2015	1	0

FIG. 1 — Lineage of K103528, 2011–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K122521	Prevent Seal	Itena Clinical	2013	1

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, K122521 (Itena Clinical, 2013) has gone furthest, with 1 descendant 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. 2011, this device’s year, is highlighted.

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	—

What is it indicated for?

IPS Empress Direct Flow is a light-curing resin-based flowable dental restorative material indicated for,

- As an intermediate or covering layer in the fabrication of esthetically demanding composite restorations

- Repair of composite restorations (in particular filling of voids, levelling out of porosities and minor chips)

- As a thin (< 0.5mm) initial layer under Class I and 11restorations

- Small restorations of all types

- Extended fissure sealing

- Splinting of mobile teeth

- Blocking out of undercuts

- Repair of composite and ceramic veneers

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K103528 · printed Nov 4, 2026

Cite this page

510(k) Report. “K103528: Ips Empress Direct Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K103528

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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