510(k) · Cleared

Cleared

Zentih Flowable Composite (Multiple)

K970683510(k) TraditionalCleared Jul 15, 1997141-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

Foremost Dental Mfg., Inc. · EBF Material, Tooth Shade, Resin

Cleared on Jul 15, 1997 after a 141-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: Jul 15, 1997
Review: 141 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 0

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

This deviceK970683 Zentih Flowable Composite (Multiple)Foremost Dental Mfg., Inc. · 1997
Descendant · cites it directly · 1 of its ownK041960 Composite/Compomer Repair KitDmg USA, Inc. · 2004
Descendant · 2 generations on · 0 of its ownK063444 Total Etch Bonding AgentDmg USA, Inc. · 2007

Most influential descendants

Showing 2 of 2 · See all

K041960Composite/Compomer Repair KitDmg USA, Inc. · 2004 · cites it directly1descendant
K063444Total Etch Bonding AgentDmg USA, Inc. · 2007 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K970683	Zentih Flowable Composite (Multiple)	Foremost Dental Mfg., Inc.	1997	—
+1	K041960	Composite/Compomer Repair Kit	Dmg USA, Inc.	2004	—
+2	K063444	Total Etch Bonding Agent	Dmg USA, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2007	1	0

FIG. 1 — Lineage of K970683, 1997–2007Source: 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
K041960	Composite/Compomer Repair Kit	Dmg USA, Inc.	2004	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, K041960 (Dmg USA, Inc., 2004) 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.

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?

Zenith Flowable Composite is a tooth-shaded resin filling material for use as an esthetic anterior restoration or base restoration under posterior or anterior composites,

Federal law restricts this device to sale by, or on the order of a dentist, or other practitioner licensed by the law of the state in which he or she practices to use or order the use of this device.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K970683 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970683: Zentih Flowable Composite (Multiple).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970683

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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