510(k) · Cleared

Recalled · 2009

Herculite Ultra

K082671510(k) TraditionalCleared Dec 11, 200887-day reviewClass II21 CFR 872.3690Recalls 1

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

Sybron Dental Specialties · EBF Material, Tooth Shade, Resin

Cleared on Dec 11, 2008 after an 87-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled once.

Decided: Dec 11, 2008
Review: 87 days
Class: Class II
Product code: EBF
Recalls: 1
Predicates: 0

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

This deviceK082671 Herculite UltraSybron Dental Specialties · 2008
Descendant · cites it directly · 1 of its ownK162257 P1145 Dental RestorativeKerr Corporation · 2016
Descendant · 2 generations on · 0 of its ownK223632 Premier's MultiMatch Universal Chameleon Restorative CompositePremier Dental Products Company · 2022

Most influential descendants

Showing 2 of 2 · See all

K162257P1145 Dental RestorativeKerr Corporation · 2016 · cites it directly1descendant
K223632Premier's MultiMatch Universal Chameleon Restorative CompositePremier Dental Products Company · 2022 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K082671	Herculite Ultra	Sybron Dental Specialties	2008	—
+1	K162257	P1145 Dental Restorative	Kerr Corporation	2016	—
+2	K223632	Premier's MultiMatch Universal Chameleon Restorative Composite	Premier Dental Products Company	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2022	1	0

FIG. 1 — Lineage of K082671, 2008–2022Source: 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
*	—	HerculiteXR V Named without a submission number			—

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
K162257	P1145 Dental Restorative	Kerr Corporation	2016	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 23, 2009	Not classified	Z-0916-2010	Labeling mix-ups	Sybron Dental Specialties is initiating a field correction on the Herculite Ultra, a dental composite restorative material, due to a mistake in the directions for use located in the Herculite technique card.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K162257 (Kerr Corporation, 2016) 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. 2008, 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?

Herculite Ultra is a dental composite restorative material intended to be used in all classes of cavities.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082671 · printed Nov 4, 2026

Cite this page

510(k) Report. “K082671: Herculite Ultra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082671

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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