510(k) · Cleared

Cleared

GC Blue Silicone

K120521510(k) TraditionalCleared May 10, 201279-day reviewClass II21 CFR 872.3660

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

GC America, Inc. · ELW Material, Impression

Cleared on May 10, 2012 as substantially equivalent to K110871 (GC America, Inc., 2011) and 2 other predicates after a 79-day review. Its family tree reaches back 3 generations to 1996.

Decided: May 10, 2012
Review: 79 days
Class: Class II
Product code: ELW
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K955932 (1996). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK955932 Exaflex Impression Material (Modification)GC America, Inc. · 1996
2 generations backK973343 HydroflexGC America, Inc. · 1997
1 generation backK110871 Fit Checker AdvancedGC America, Inc. · 2011
This deviceK120521 GC Blue SiliconeGC America, Inc. · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K955932	Exaflex Impression Material (Modification)	GC America, Inc.	1996	—
−2	K973343	Hydroflex	GC America, Inc.	1997	—
−1	K110871	Fit Checker Advanced	GC America, Inc.	2011	—
0 (this device)	K120521	GC Blue Silicone	GC America, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2005	1	0

FIG. 1 — Lineage of K120521, 1996–2012Source: 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 ELW? 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 ELW device

#1 K254152 Dia-X Sil Light Bodyscore 14.1 · 8 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? (3)

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
*	K110871	Fit Checker Advanced Summary page 1 …k) Code ___________No. No -Fit Checker Advanced GC AMERICA, [NC K110871 ELW Fit Checker 11 GC AMERICA, INC K032289 ELW _GC Fusion (EXA'lence)…	GC America, Inc.	2011	—
*	K032289	Fit Checker II Summary page 1 …No -Fit Checker Advanced GC AMERICA, [NC K110871 ELW Fit Checker 11 GC AMERICA, INC K032289 ELW _GC Fusion (EXA'lence) GC AMERICA, INC K04 1398 ELW 4. Description of Device:…	GC America, Inc.	2003	—
*	K041398	GC Fusion Summary page 1 …71 ELW Fit Checker 11 GC AMERICA, INC K032289 ELW _GC Fusion (EXA'lence) GC AMERICA, INC K04 1398 ELW 4. Description of Device: GC BLUE SILICONE is available in a 2-pant cartridge device in which part I s a base…	GC America, Inc.	2004	—

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?

The line of descent spans 16 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
None of the 6 ancestors has a recall.

How does its category compare?

All ELW devices

ELW Material, Impression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · ELW

2in 2025

2007high 11 (2008) · low 2 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ELW

98in 2024

2007high 268 (2026) · low 30 (2008)2026

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

Recalls per year · ELW

3in 2016

2007high 3 (2013) · low 0 (2007)2026

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

Adverse event reports per year · ELW

22in 2025

2007high 35 (2014) · low 3 (2024)2025

MAUDE reports naming product code ELW, 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	7	60	0	9
2008	11	30	0	17
2009	7	43	0	7
2010	5	88	1	16
2011	9	83	0	15
2012	7	87	1	14
2013	5	67	3	32
2014	11	122	0	35
2015	8	93	0	18
2016	7	166	3	15
2017	3	89	0	17
2018	5	126	0	14
2019	2	—	0	24
2020	4	99	0	8
2021	3	76	0	6
2022	7	60	0	9
2023	2	—	0	13
2024	3	98	0	3
2025	2	—	0	22
2026	3	268	0	—

What is it indicated for?

GC BLUE SILICONE is a silicone impression material for fit check by detecting the high spots and pressure points of ceramic crowns, ceramic bridges, ceramic inlays and the occlusal surface.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120521 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120521: GC Blue Silicone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120521

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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