510(k) · Cleared

Recalled · Class II · 2023

Dentemp One Step

K964773510(k) TraditionalCleared Feb 21, 199786-day reviewClass II21 CFR 872.3275Recalls 2

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

Majestic Drug Co., Inc. · EMA Cement, Dental

Cleared on Feb 21, 1997 after an 86-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.

Decided: Feb 21, 1997
Review: 86 days
Class: Class II
Product code: EMA
Recalls: 2
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK964773 Dentemp One StepMajestic Drug Co., Inc. · 1997
Descendant · cites it directly · 0 of its ownK982692 Sternomega Bonding Agent, Sternomega Composite LC, Sternomega…Sterngold/Implamed · 1998

Most influential descendants

Showing 1 of 1 · See all

K982692Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LCSterngold/Implamed · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K964773	Dentemp One Step	Majestic Drug Co., Inc.	1997	—
+1	K982692	Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LC	Sterngold/Implamed	1998	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K964773, 1997–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K982692	Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LC	Sterngold/Implamed	1998	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 4, 2023	Class II	Z-0265-2024	Storage	Products were stored outside of labeled temperature requirements.
Jun 23, 2022	Class II	Z-1529-2022	Storage	Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K982692 (Sterngold/Implamed, 1998) has gone furthest, with 0 descendants of its own.

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	—

https://510kreport.com/device/K964773 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964773: Dentemp One Step.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964773

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026