510(k) · Cleared

Cleared

Glasionomer FX-II

K031467510(k) TraditionalCleared Jul 17, 200370-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, 2003 as substantially equivalent to K961448 (GC America, Inc., 1996) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 1994.

Decided: Jul 17, 2003
Review: 70 days
Class: Class II
Product code: EMA
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K940122 (1994). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK940122 HY Bond, Glasionomer CXShofu Dental Corp. · 1994
This deviceK031467 Glasionomer FX-IIShofu Dental Corp. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K940122	HY Bond, Glasionomer CX	Shofu Dental Corp.	1994	—
0 (this device)	K031467	Glasionomer FX-II	Shofu Dental Corp.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

FIG. 1 — Lineage of K031467, 1994–2003Source: 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? (2)

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
*	K961448	Fuji IX GP Summary page 1 …assification EMA Product Code 872.3275tb) Substantially Equivalent Devices Fuji GP [51O(k) Number - K9614481 Hy Bond Glasionomer CX [51O(k) Number - K9…	GC America, Inc.	1996	—
*	K940122	HY Bond, Glasionomer CX Summary page 1 …Fuji GP [51O(k) Number - K9614481 Hy Bond Glasionomer CX [51O(k) Number - K9401221 Description of Glasionomer FX-II Glasionomer FX-II is a glass polyalkenoate cement used for dental restorations, for Minimal…	Shofu Dental Corp.	1994	—

Also cleared against K961448: 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?

None of the 2 ancestors has a recall.
3 other devices also cite its predicate K961448.

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?

Glasionomer FX-II is a glass polyalkenoate cement used for dental restorations

Glasionomer FX-II is intended for use as a final restorative for deciduous teeth; a geriatric restorative for Class I, 11, Ill and V cavities and cervical erosions; a final restorative for Class I and 11 of adult dentition in non-load bearing situations; an intermediate restorative for heavy stress cavities; a core build up; and for pit and fissure fillings.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031467 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031467: Glasionomer FX-II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031467

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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