510(k) · Cleared

Cleared

Sternomega Compomer Cement

K982895510(k) TraditionalCleared Oct 9, 199853-day reviewClass II21 CFR 872.3275

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

Cleared on Oct 9, 1998 as substantially equivalent to K940513 (Kerr Corporation (Danbury), 1994) and 8 other predicates after a 53-day review. Its family tree reaches back 1 generation to 1992.

Decided: Oct 9, 1998
Review: 53 days
Class: Class II
Product code: EMA
Recalls: None
Predicates: 10

Its longest line of descent runs back 1 generation to K924151 (1992). 9 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK924151 Bisco D/C ResinomerBisco, Inc. · 1992
This deviceK982895 Sternomega Compomer CementSterngold/Implamed · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K924151	Bisco D/C Resinomer	Bisco, Inc.	1992	—
0 (this device)	K982895	Sternomega Compomer Cement	Sterngold/Implamed	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1994	5	0
1995	1	0
1996	1	0

FIG. 1 — Lineage of K982895, 1992–1998Source: 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 EMA? 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 EMA device

#1 K254109 G-Cem Universalscore 15.0 · 13 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K940513	Optibond Summary page 1 …substantially equivalent to a number of currently marketed dental cements and bonding agents including the following: . Product/Siogy# ¢ Manufacturer, . .. oo ‘Optibond/K940513 + Kerr ~ . s Panavia 21/K933030 Kuraray/J. Morita C&B Luting Composite/K940030 Bisco Flexi-Flow/K922249 EDS C&B Metabond/K96…	Kerr Corporation (Danbury)	1994	—
*	K933030	Panavia 21 Summary page 1 …er of currently marketed dental cements and bonding agents including the following: . Product/Siogy# ¢ Manufacturer, . .. oo ‘Optibond/K940513 + Kerr ~ . s Panavia 21/K933030 Kuraray/J. Morita C&B Luting Composite/K940030 Bisco Flexi-Flow/K922249 EDS C&B Metabond/K960464 Parkell Duolink/K943596 Bisc…	Kuraray Co.	1994	—
*	K940030	Bisco Composite Summary page 1 …ing agents including the following: . Product/Siogy# ¢ Manufacturer, . .. oo ‘Optibond/K940513 + Kerr ~ . s Panavia 21/K933030 Kuraray/J. Morita C&B Luting Composite/K940030 Bisco Flexi-Flow/K922249 EDS C&B Metabond/K960464 Parkell Duolink/K943596 Bisco Variolink/931309 Vivadent Advance/K940914 De…	Bisco, Inc.	1994	—
*	K922249	Flexi-Flow Cement Natural Summary page 1 …ollowing: . Product/Siogy# ¢ Manufacturer, . .. oo ‘Optibond/K940513 + Kerr ~ . s Panavia 21/K933030 Kuraray/J. Morita C&B Luting Composite/K940030 Bisco Flexi-Flow/K922249 EDS C&B Metabond/K960464 Parkell Duolink/K943596 Bisco Variolink/931309 Vivadent Advance/K940914 Dentsply Dyract Cem/Unknown…	Essential Dental Systems, Inc.	1994	—
*	K960464	C & B Metabond (Modification) Summary page 1 …¢ Manufacturer, . .. oo ‘Optibond/K940513 + Kerr ~ . s Panavia 21/K933030 Kuraray/J. Morita C&B Luting Composite/K940030 Bisco Flexi-Flow/K922249 EDS C&B Metabond/K960464 Parkell Duolink/K943596 Bisco Variolink/931309 Vivadent Advance/K940914 Dentsply Dyract Cem/Unknown Dentsply Fuji Duet (Fuji…	Parkell, Inc.	1996	—
Kept off the family tree	K943596	FDA’s K943596 is Vantage, for Adac Gamma Cameras Our OCR of the scanned summary read K943596, FDA’s number for Vantage, for Adac Gamma Cameras (Adac Laboratories). Its FDA name has none of the distinctive words the summary uses for the device it names, “Duolink”. Kept off the family tree. Summary page 1 …‘Optibond/K940513 + Kerr ~ . s Panavia 21/K933030 Kuraray/J. Morita C&B Luting Composite/K940030 Bisco Flexi-Flow/K922249 EDS C&B Metabond/K960464 Parkell Duolink/K943596 Bisco Variolink/931309 Vivadent Advance/K940914 Dentsply Dyract Cem/Unknown Dentsply Fuji Duet (Fuji Plus)/K946100 GC Resino…	Adac Laboratories	1995	—
*	K931309	Variolink Summary page 1 …r ~ . s Panavia 21/K933030 Kuraray/J. Morita C&B Luting Composite/K940030 Bisco Flexi-Flow/K922249 EDS C&B Metabond/K960464 Parkell Duolink/K943596 Bisco Variolink/931309 Vivadent Advance/K940914 Dentsply Dyract Cem/Unknown Dentsply Fuji Duet (Fuji Plus)/K946100 GC Resinomer/K924151 Bisco Cemen…	Ivoclar North America, Inc.	1993	—
*	K940914	New Luting Cement Material (NLC) Summary page 1 …30 Kuraray/J. Morita C&B Luting Composite/K940030 Bisco Flexi-Flow/K922249 EDS C&B Metabond/K960464 Parkell Duolink/K943596 Bisco Variolink/931309 Vivadent Advance/K940914 Dentsply Dyract Cem/Unknown Dentsply Fuji Duet (Fuji Plus)/K946100 GC Resinomer/K924151 Bisco Cement-It/Unknown Jeneric/Pentr…	Dentsply Intl.	1994	—
*	K946100	Fuji Duet Summary page 1 …K922249 EDS C&B Metabond/K960464 Parkell Duolink/K943596 Bisco Variolink/931309 Vivadent Advance/K940914 Dentsply Dyract Cem/Unknown Dentsply Fuji Duet (Fuji Plus)/K946100 GC Resinomer/K924151 Bisco Cement-It/Unknown Jeneric/Pentron ABC Dual Adhesive Bridge Cement/ Vivadent Unknown Product Desc…	GC America, Inc.	1995	—
*	K924151	Bisco D/C Resinomer Summary page 1 …ond/K960464 Parkell Duolink/K943596 Bisco Variolink/931309 Vivadent Advance/K940914 Dentsply Dyract Cem/Unknown Dentsply Fuji Duet (Fuji Plus)/K946100 GC Resinomer/K924151 Bisco Cement-It/Unknown Jeneric/Pentron ABC Dual Adhesive Bridge Cement/ Vivadent Unknown Product Description: The SternOme…	Bisco, Inc.	1992	—
*	—	Dyract Cem Named without a submission number			—
*	—	Cement-It Named without a submission number			—
*	—	ABC Dual Adhesive Bridge Cement Named without a submission number			—

Also cleared against K940513: 2 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?

None of the 9 ancestors has a recall.
2 other devices also cite its predicate K940513.

How does its category compare?

All EMA devices

EMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EMA

10in 2025

2007high 14 (2010) · low 2 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EMA

106in 2025

2007high 245 (2022) · low 48 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EMA

1in 2023

2007high 5 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EMA

9in 2025

2007high 385 (2013) · low 3 (2022)2025

MAUDE reports naming product code EMA, 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	6	48	0	33
2008	13	71	2	50
2009	10	86	1	90
2010	14	86	1	106
2011	8	79	5	224
2012	10	128	0	249
2013	12	178	0	385
2014	4	174	0	207
2015	9	134	0	85
2016	10	182	0	16
2017	3	141	0	13
2018	3	237	0	4
2019	7	127	0	12
2020	8	164	0	5
2021	4	184	0	8
2022	7	245	0	3
2023	2	—	1	6
2024	3	59	0	5
2025	10	106	0	9
2026	7	150	0	—

What is it indicated for?

SternOmega Compomer Cement Automix is indicated for use in permanent luting of crowns, bridges, inlays and onlays and for luting ceramic crowns, inlays and veneers.

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/K982895 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982895: Sternomega Compomer Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982895

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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