510(k) · Cleared

Cleared

LC Microhybrid

K984484510(k) TraditionalCleared Jan 20, 199935-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 & C Polymer GmbH · EBF Material, Tooth Shade, Resin

Cleared on Jan 20, 1999 as substantially equivalent to K960565 (Dent Zar, Inc., 1996) after a 35-day review. Its family tree reaches back 1 generation to 1996.

Decided: Jan 20, 1999
Review: 35 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K960565 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK960565 Acorn Anterior/Posterior Composite RestorativeDent Zar, Inc. · 1996
This deviceK984484 LC MicrohybridS & C Polymer GmbH · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K960565	Acorn Anterior/Posterior Composite Restorative	Dent Zar, Inc.	1996	—
0 (this device)	K984484	LC Microhybrid	S & C Polymer GmbH	1999	—

FIG. 1 — Lineage of K984484, 1996–1999Source: 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
*	K960565	Acorn Anterior/Posterior Composite Restorative Summary page 1 …CROHYBRID material is the same as "ACORN", a product manufactured by S & C Polymer GmbH for Dent Zar International, 19643 Trull Brook Dr., Tarzana, CA 91356, USA, 510(k) K960565. S & C Polymer GmbH's intended use, performance, indications, proposdd labels and instructions for use (see attached) are substan…	Dent Zar, Inc.	1996	—

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.

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?

LC MICROHYBRID is a light cure micro hybride composite for tooth fillings.

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/K984484 · printed Nov 5, 2026

Cite this page

510(k) Report. “K984484: LC Microhybrid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984484

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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