510(k) · Cleared

Cleared

GC Fujicem

K001730510(k) TraditionalCleared Jul 17, 200040-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 Jul 17, 2000 after a 40-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 17 later devices descend from it.

Decided: Jul 17, 2000
Review: 40 days
Class: Class II
Product code: EMA
Recalls: None
Predicates: 0

17 later devices descend from it, 3 citing it directly.

This deviceK001730 GC FujicemGC America, Inc. · 2000
Descendant · cites it directly · 15 of its ownK022476 Relyx Rmgip3M Company · 2002
Descendant · 2 generations on · 10 of its ownK111185 Relyx Luting Plus Automix3M Espe Dental Products · 2011
Descendant · 3 generations on · 5 of its ownK123265 Rmgi Low ViscosityPulpdent Corporation · 2012
Descendant · 4 generations on · 4 of its ownK130223 Rmgi FillPulpdent Corporation · 2013
Descendant · cites it directly · 1 of its ownK182854 GC FujiCEM 2 (Improved)GC America, Inc. · 2019

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2002high 3 (2013) · low 0 (2004)2026

Most influential descendants

Showing 5 of 17 · See all

K022476Relyx Rmgip3M Company · 2002 · cites it directly15descendants
K111185Relyx Luting Plus Automix3M Espe Dental Products · 2011 · 2 generations on10descendants
K123265Rmgi Low ViscosityPulpdent Corporation · 2012 · 3 generations on5descendants
K130223Rmgi FillPulpdent Corporation · 2013 · 4 generations on4descendants
K182854GC FujiCEM 2 (Improved)GC America, Inc. · 2019 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001730	GC Fujicem	GC America, Inc.	2000	—
+1	K022476	Relyx Rmgip	3M Company	2002	—
+2	K111185	Relyx Luting Plus Automix	3M Espe Dental Products	2011	—
+3	K123265	Rmgi Low Viscosity	Pulpdent Corporation	2012	—
+4	K130223	Rmgi Fill	Pulpdent Corporation	2013	—
+1	K182854	GC FujiCEM 2 (Improved)	GC America, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	2	0
2011	1	0
2012	1	0
2013	3	0
2016	1	0
2017	1	0
2019	2	0
2020	1	0
2021	1	0
2022	1	0
2025	2	0

FIG. 1 — Lineage of K001730, 2000–2025Source: 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
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

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? (17)

See all 17

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K022476	Relyx Rmgip	3M Company	2002	15
K182854	GC FujiCEM 2 (Improved)	GC America, Inc.	2019	1
K191122	3M RelyX Pediatric Resin Modified Glass Ionomer Cement	3M Espe Dental Products	2019	0

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?

Of its descendants, K022476 (3M Company, 2002) has gone furthest, with 15 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/K001730 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001730: GC Fujicem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001730

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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