510(k) · Cleared

Cleared

GC Fuji Direct

K172382510(k) TraditionalCleared Apr 2, 2018237-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 Apr 2, 2018 as substantially equivalent to K051427 (GC America, Inc., 2005) after a 237-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.

Decided: Apr 2, 2018
Review: 237 days
Class: Class II
Product code: EMA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K051427 (2005). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK051427 GC Fuji Fil LCGC America, Inc. · 2005
This deviceK172382 GC Fuji DirectGC America, Inc. · 2018
Descendant · cites it directly · 0 of its ownK192530 Surefil one Self-adhesive Composite HybridDentsply Sirona · 2020

Most influential descendants

Showing 1 of 1 · See all

K192530Surefil one Self-adhesive Composite HybridDentsply Sirona · 2020 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K051427	GC Fuji Fil LC	GC America, Inc.	2005	—
0 (this device)	K172382	GC Fuji Direct	GC America, Inc.	2018	—
+1	K192530	Surefil one Self-adhesive Composite Hybrid	Dentsply Sirona	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0

FIG. 1 — Lineage of K172382, 2005–2020Source: 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? (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
*	K051427	GC Fuji Fil LC Summary page 4 …ices: Product Applicant 510(k) No. Code No Predicate Decision Date GC FUJI FILLING LC GC America Inc. K051427 EMA Primary 08/22/2005 GC Fuji II LC Capsule GC America Inc. K993973 EMA…	GC America, Inc.	2005	—
†	K993973	Fuji II LC Capsule	GC America, Inc.	2000	—
†	K001730	GC Fujicem	GC America, Inc.	2000	—
†	K082434	GDLS-200	GC America, Inc.	2008	—

Also cleared against K051427: 3 other devices →

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
K192530	Surefil one Self-adhesive Composite Hybrid	Dentsply Sirona	2020	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?

Its one ancestor has no recall.
Of its descendants, K192530 (Dentsply Sirona, 2020) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K051427.

How does its category compare?

All EMA devices

EMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

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?

1. Class III and V restorations

2. Restoration of primary teeth

3. Core build-up

4. Cases where radiopacity is required

5. Base material for Class I and Class II cavities using a sandwich laminate technique.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K172382 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172382: GC Fuji Direct.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172382

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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