510(k) · Cleared

Cleared

GC Initial MC, AL and LF

K040567510(k) TraditionalCleared Apr 22, 200449-day reviewClass II21 CFR 872.6660

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

GC America, Inc. · EIH Powder, Porcelain

Cleared on Apr 22, 2004 as substantially equivalent to K981490 (Jensen Industries, Inc., 1998) and 2 other predicates after a 49-day review. Its family tree reaches back 2 generations to 1990.

Decided: Apr 22, 2004
Review: 49 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K900209 (1990). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK900209 Willi Geller Ceramic Creation & SurpriseCreation North America, Inc. · 1990
1 generation backK981490 Willi Geller Creation PorcelainJensen Industries, Inc. · 1998
This deviceK040567 GC Initial MC, AL and LFGC America, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K900209	Willi Geller Ceramic Creation & Surprise	Creation North America, Inc.	1990	—
−1	K981490	Willi Geller Creation Porcelain	Jensen Industries, Inc.	1998	—
0 (this device)	K040567	GC Initial MC, AL and LF	GC America, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	2	0

FIG. 1 — Lineage of K040567, 1990–2004Source: 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 EIH? 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 EIH device

#1 K192231 Dental Glass Ceramics Blocksscore 15.2 · 3 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
*	K981490	Willi Geller Creation Porcelain Summary page 1 …I medical device Product Code ElH Regulation Number 872.6660 Legally marketed equiv. devices: Willi Geller Creation& CC Porcelain 5 10(k) #K981490 Willi Geller Creation& AV Porcelain 510(k) #K002041 Willi G…	Jensen Industries, Inc.	1998	—
*	K002041	Willi Geller Creation & AV Porcelain Summary page 1 …0 Legally marketed equiv. devices: Willi Geller Creation& CC Porcelain 5 10(k) #K981490 Willi Geller Creation& AV Porcelain 510(k) #K002041 Willi Geller Creation& LF Porcelain 510(k) #K002904 Description of the Device: The GC…	Jensen Industries, Inc.	2000	—
*	K002904	Willi Geller Creation and LF Porcelain Summary page 1 …490 Willi Geller Creation& AV Porcelain 510(k) #K002041 Willi Geller Creation& LF Porcelain 510(k) #K002904 Description of the Device: The GC Initial dental ceramic system is a feldspathic porcelain…	Jensen Industries, Inc.	2000	—

Also cleared against K981490: 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?

The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 8.5 years on median.
None of the 4 ancestors has a recall.
3 other devices also cite its predicate K981490.

How does its category compare?

All EIH devices

EIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EIH

13in 2025

2007high 28 (2024) · low 9 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EIH

84in 2025

2007high 187 (2016) · low 63 (2007)2026

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

Recalls per year · EIH

1in 2025

2007high 21 (2016) · low 0 (2007)2026

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

Adverse event reports per year · EIH

1in 2025

2007high 22 (2021) · low 0 (2007)2025

MAUDE reports naming product code EIH, 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	15	63	0	0
2008	15	87	0	1
2009	15	79	0	0
2010	14	89	0	0
2011	14	80	0	1
2012	9	96	0	0
2013	16	107	0	6
2014	18	118	0	1
2015	23	118	0	0
2016	22	187	21	4
2017	16	149	0	1
2018	10	139	0	2
2019	16	125	0	1
2020	13	155	0	0
2021	17	131	0	22
2022	16	89	0	0
2023	15	114	0	0
2024	28	89	0	7
2025	13	84	1	1
2026	14	73	0	—

What is it indicated for?

This product is intended for use in fabricating oral crowns, bridges, laminate veneers,

inlays and onlays for dental use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040567 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040567: GC Initial MC, AL and LF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040567

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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