510(k) · Cleared

Cleared

Adhesive Hybrid Ionomer Cement

K974140510(k) TraditionalCleared Jan 5, 199863-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 Jan 5, 1998 as substantially equivalent to K940914 (Dentsply Intl., 1994) after a 63-day review. Its family tree reaches back 1 generation to 1994.

Decided: Jan 5, 1998
Review: 63 days
Class: Class II
Product code: EMA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K940914 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK940914 New Luting Cement Material (NLC)Dentsply Intl. · 1994
This deviceK974140 Adhesive Hybrid Ionomer CementDentsply Intl. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K940914	New Luting Cement Material (NLC)	Dentsply Intl.	1994	—
0 (this device)	K974140	Adhesive Hybrid Ionomer Cement	Dentsply Intl.	1998	—

FIG. 1 — Lineage of K974140, 1994–1998Source: 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
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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
*	K940914	New Luting Cement Material (NLC) Summary page 1 …October 31, 1997 TRADE OR PROPRIETARY NAME: ADHESIVE HYBRID IONOMER CEMENT CLASSIFICATION NAME: Dental Cement 872.3275 PREDICATE DEVICE: Advance® Hybrid lonomer Cement K940914 DEVICE DESCRIPTION: ADHESIVE HYBRID IONOMER CEMENT is a two-component, dual- cure, high-strength hybrid ionomer dental cement us…	Dentsply Intl.	1994	—

Also cleared against K940914: 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?

Its one ancestor has no recall.
2 other devices also cite its predicate K940914.

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?

ADHESIVE HYBRID IONOMER CEMENT is used for:

Adhesive cementation of all metal crowns and bridges including precious, semi-precious and non-precious metals

Adhesive cementation of conventional porcelain fused to metal crowns and bridges with metal margins

Adhesive cementation of gold inlays and onlays

Adhesive cementation of prefabricated and cast posts.

Adhesive cementation of porcelain/ceramic/composite substrate crowns

Adhesive cementation of porcelain jacket crowns (including foil or electroplated lined crowns)

Adhesive cementation of porcelain fused to metal (PFM) crowns with porcelain margins

Adhesive liner for bonding freshly placed direct amalgam restorations

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/K974140 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974140: Adhesive Hybrid Ionomer Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974140

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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