510(k) · Cleared

Cleared

Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LC

K982692510(k) AbbreviatedCleared Oct 22, 199880-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

Sterngold/Implamed · EBF Material, Tooth Shade, Resin

Cleared on Oct 22, 1998 as substantially equivalent to K962348 (Dentsply Intl., 1996) and 12 other predicates after an 80-day review. Its family tree reaches back 3 generations to 1993.

Decided: Oct 22, 1998
Review: 80 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 13

Its longest line of descent runs back 3 generations to K931812 (1993). 20 ancestors in all, the oldest K844662 (1985). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
2 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
1 generation backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
This deviceK982692 Sternomega Bonding Agent, Sternomega Composite LC, Sternomega…Sterngold/Implamed · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K931812	New Dentine Adhesive	Dentsply Intl.	1993	—
−2	K960823	Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent	Dentsply Intl.	1996	—
−1	K962348	Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent	Dentsply Intl.	1996	—
0 (this device)	K982692	Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LC	Sterngold/Implamed	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1990	2	0
1992	2	0
1993	1	0
1994	3	0
1995	3	0
1996	2	0
1997	3	0

FIG. 1 — Lineage of K982692, 1993–1998Source: 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? (13)

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
*	K962348	Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent Summary page 1 …ation: According to Section 513 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class II. Predicate Devices: Dmepa Bondin ot Prime & Bond 2.1 K962348 Dentsply Int’l. Optibond Solo Single Component K940513 Kerr Mfg. Co. Dentemp One Step K964773 Bisco (Majestic Drug Co.) Bond 1 K…	Dentsply Intl.	1996	—
*	K940513	Optibond Summary page 1 …ug, and Cosmetic Act, the device classification is Class II. Predicate Devices: Dmepa Bondin ot Prime & Bond 2.1 K962348 Dentsply Int’l. Optibond Solo Single Component K940513 Kerr Mfg. Co. Dentemp One Step K964773 Bisco (Majestic Drug Co.) Bond 1 K973388 Jeneric/Pentron Inc. Singl XRV Herculite K8446…	Kerr Corporation (Danbury)	1994	—
*	K964773	Dentemp One Step Summary page 1 …fication is Class II. Predicate Devices: Dmepa Bondin ot Prime & Bond 2.1 K962348 Dentsply Int’l. Optibond Solo Single Component K940513 Kerr Mfg. Co. Dentemp One Step K964773 Bisco (Majestic Drug Co.) Bond 1 K973388 Jeneric/Pentron Inc. Singl XRV Herculite K844662 Kerr Mfg. Co. Prodigy AC K963805 Sy…	Majestic Drug Co., Inc.	1997	2
*	K973388	Dentin Conditioning and Adhesive (Bond 1) Summary page 1 …Dmepa Bondin ot Prime & Bond 2.1 K962348 Dentsply Int’l. Optibond Solo Single Component K940513 Kerr Mfg. Co. Dentemp One Step K964773 Bisco (Majestic Drug Co.) Bond 1 K973388 Jeneric/Pentron Inc. Singl XRV Herculite K844662 Kerr Mfg. Co. Prodigy AC K963805 Sybron Dental Specialties Renamel Hybrid K92…	Jeneric/Pentron, Inc.	1997	2
*	K844662	Kerr Herculite Dental Composite Restorative Materi Summary page 1 …Int’l. Optibond Solo Single Component K940513 Kerr Mfg. Co. Dentemp One Step K964773 Bisco (Majestic Drug Co.) Bond 1 K973388 Jeneric/Pentron Inc. Singl XRV Herculite K844662 Kerr Mfg. Co. Prodigy AC K963805 Sybron Dental Specialties Renamel Hybrid K921820 Cosmedent, Inc. Charisma K932013 Heraeus Kulze…	Kerr Corporation (Danbury)	1985	—
*	K963805	Prodigy AC Summary page 1 …ent K940513 Kerr Mfg. Co. Dentemp One Step K964773 Bisco (Majestic Drug Co.) Bond 1 K973388 Jeneric/Pentron Inc. Singl XRV Herculite K844662 Kerr Mfg. Co. Prodigy AC K963805 Sybron Dental Specialties Renamel Hybrid K921820 Cosmedent, Inc. Charisma K932013 Heraeus Kulzer Tetric Ceram K964285 Ivoclar No…	Sybron Dental Specialties, Inc.	1996	—
*	K921820	Renamel Esthetic Restorative System, Modification Summary page 1 …3 Bisco (Majestic Drug Co.) Bond 1 K973388 Jeneric/Pentron Inc. Singl XRV Herculite K844662 Kerr Mfg. Co. Prodigy AC K963805 Sybron Dental Specialties Renamel Hybrid K921820 Cosmedent, Inc. Charisma K932013 Heraeus Kulzer Tetric Ceram K964285 Ivoclar North America K922569 , Ivoclar North America Com…	Cosmedent, Inc.	1992	—
*	K932013	Charisma -- Modified Summary page 1 …1 K973388 Jeneric/Pentron Inc. Singl XRV Herculite K844662 Kerr Mfg. Co. Prodigy AC K963805 Sybron Dental Specialties Renamel Hybrid K921820 Cosmedent, Inc. Charisma K932013 Heraeus Kulzer Tetric Ceram K964285 Ivoclar North America K922569 , Ivoclar North America Compbg"iéés' ” B K951836 Ivoclar Nor…	Heraeus Kulzer, Inc.	1993	—
*	K964285	Tetric Ceram Summary page 1 …l XRV Herculite K844662 Kerr Mfg. Co. Prodigy AC K963805 Sybron Dental Specialties Renamel Hybrid K921820 Cosmedent, Inc. Charisma K932013 Heraeus Kulzer Tetric Ceram K964285 Ivoclar North America K922569 , Ivoclar North America Compbg"iéés' ” B K951836 Ivoclar North America Dyract K950991 Dentsply In…	Ivoclar North America, Inc.	1997	—
*	K922569	Tetric Light-Curing Composite Summary page 1 …fg. Co. Prodigy AC K963805 Sybron Dental Specialties Renamel Hybrid K921820 Cosmedent, Inc. Charisma K932013 Heraeus Kulzer Tetric Ceram K964285 Ivoclar North America K922569 , Ivoclar North America Compbg"iéés' ” B K951836 Ivoclar North America Dyract K950991 Dentsply Int’l. Hytac Aplitip K962442 ESPE…	Ivoclar North America, Inc.	1992	—
*	K951836	Compolglass Compoglass Sca Summary page 1 …ies Renamel Hybrid K921820 Cosmedent, Inc. Charisma K932013 Heraeus Kulzer Tetric Ceram K964285 Ivoclar North America K922569 , Ivoclar North America Compbg"iéés' ” B K951836 Ivoclar North America Dyract K950991 Dentsply Int’l. Hytac Aplitip K962442 ESPE Product Description: The SternOmega Bonding Age…	Ivoclar North America, Inc.	1995	—
*	K950991	Dyract II Restorative Summary page 1 …Inc. Charisma K932013 Heraeus Kulzer Tetric Ceram K964285 Ivoclar North America K922569 , Ivoclar North America Compbg"iéés' ” B K951836 Ivoclar North America Dyract K950991 Dentsply Int’l. Hytac Aplitip K962442 ESPE Product Description: The SternOmega Bonding Agent is a light-curing, one-component b…	Dentsply Intl.	1995	—
*	K962442	Hytac Aplitip/Hytac Osb Summary page 1 …Tetric Ceram K964285 Ivoclar North America K922569 , Ivoclar North America Compbg"iéés' ” B K951836 Ivoclar North America Dyract K950991 Dentsply Int’l. Hytac Aplitip K962442 ESPE Product Description: The SternOmega Bonding Agent is a light-curing, one-component bonding agent for compomer and composit…	Espe GmbH & Co. Kg.	1996	—

Also cleared against K962348: 3 other devices →

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?

The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
2 of the 20 ancestors have a recall of any class.
3 other devices also cite its predicate K962348.

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?

The SternOmega Dental Composite System is indicated for dental filling of cavities.

The SternOmega Composite LC is indicated for filling of all classes of cavities.

The SternOmega Compomer LC is indicated for Class V restorations, cervical abrasions and erosions, Class III restorations, and for restorations of all cavity classes including Classes I and II in deciduous teeth.

The SternOmega Bonding Agent is indicated for all adhesive restorations with compomers and composites, including the SternOmega Composite LC and the SternOmega Compomer LC.

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/K982692 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982692: Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982692

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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