510(k) · Cleared

Cleared

Duceram Plus Ceramic System

K040420510(k) TraditionalCleared Mar 18, 200429-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

Cleared on Mar 18, 2004 as substantially equivalent to K871808 (Degussa Dental, Inc., 1987) after a 29-day review. Its family tree reaches back 1 generation to 1987. 2 later devices descend from it.

Decided: Mar 18, 2004
Review: 29 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K871808 (1987). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK871808 Duceram-Metal-Ceramic Dental Porcelain SystemDegussa Dental, Inc. · 1987
This deviceK040420 Duceram Plus Ceramic SystemDentsply Intl. · 2004
Descendant · cites it directly · 1 of its ownK062504 CeramaxAlphadent Co., Ltd. · 2006
Descendant · 2 generations on · 0 of its ownK081200 Dental Porcelain (Glass Powder), Top-Ceram T-1, T1, T2, T3, T4Global Top, Inc. · 2008

Most influential descendants

Showing 2 of 2 · See all

K062504CeramaxAlphadent Co., Ltd. · 2006 · cites it directly1descendant
K081200Dental Porcelain (Glass Powder), Top-Ceram T-1, T1, T2, T3, T4Global Top, Inc. · 2008 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K871808	Duceram-Metal-Ceramic Dental Porcelain System	Degussa Dental, Inc.	1987	—
0 (this device)	K040420	Duceram Plus Ceramic System	Dentsply Intl.	2004	—
+1	K062504	Ceramax	Alphadent Co., Ltd.	2006	—
+2	K081200	Dental Porcelain (Glass Powder), Top-Ceram T-1, T1, T2, T3, T4	Global Top, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	1	0

FIG. 1 — Lineage of K040420, 1987–2008Source: 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? (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
*	K871808	Duceram-Metal-Ceramic Dental Porcelain System Summary page 1 …linical use (872.6660) PREDICATE DEVICES: DUCERAM Metal Ceramic Dental Porcelain System K87 1808 DEVICE DESCRIPTION: The DUCERAM® PLUS CERAMIC SYSTEM is a dental ceramic veneering system for metal framework and copings. They…	Degussa Dental, Inc.	1987	—

Also cleared against K871808: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K062504	Ceramax	Alphadent Co., Ltd.	2006	1

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, K062504 (Alphadent Co., Ltd., 2006) has gone furthest, with 1 descendant of its own.
1 other device also cites its predicate K871808.

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?

Veneering of metal framework and copings for the preparation of crowns and bridges

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040420 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040420: Duceram Plus Ceramic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040420

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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