510(k) · Cleared

Cleared

Super-Dent Etching Gel, Super-Dent Micro-Etch Gel and Super-Dent Etching Gel Syringe Tips

K964179510(k) TraditionalCleared Jan 9, 199783-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

S.S. White Mfg., Ltd. · EBF Material, Tooth Shade, Resin

Cleared on Jan 9, 1997 as substantially equivalent to K890464 (Foremost Dental Mfg., Inc., 1989) after an 83-day review. Its family tree reaches back 1 generation to 1989.

Decided: Jan 9, 1997
Review: 83 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K890464 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK890464 Zenith 40% Phosphoric Acid GelForemost Dental Mfg., Inc. · 1989
This deviceK964179 Super-Dent Etching Gel, Super-Dent Micro-Etch Gel and Super-Dent…S.S. White Mfg., Ltd. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K890464	Zenith 40% Phosphoric Acid Gel	Foremost Dental Mfg., Inc.	1989	—
0 (this device)	K964179	Super-Dent Etching Gel, Super-Dent Micro-Etch Gel and Super-Dent Etching Gel…	S.S. White Mfg., Ltd.	1997	—

FIG. 1 — Lineage of K964179, 1989–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K890464	Zenith 40% Phosphoric Acid Gel Summary page 2 …ON NAME: Phosphoric acid etching gel CLASSIFICATION NAME: Dental cement accessory, phosphoric acid etching gel EQUIVALENT TO: Zenith 40% Phosphoric Acid Gel 510(k) No. K890464 DESCRIPTION: These materials consist of a gel containing ortho-phosphoric acid. INTENDED USE: These materials are intended fo…	Foremost Dental Mfg., Inc.	1989	—

Also cleared against K890464: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

Its one ancestor has no recall.
1 other device also cites its predicate K890464.

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?

These materials are intended for use in preparation of tooth material prior to restoration by etching of the surface.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K964179 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964179: Super-Dent Etching Gel, Super-Dent Micro-Etch Gel and Super-Dent Etching Gel Syringe Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964179

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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