510(k) · Cleared

Cleared

Carrara Porcelain and Carrara Vincent Porcelain

K981000510(k) TraditionalCleared May 15, 199858-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

European Dental Imports, Inc. · EIH Powder, Porcelain

Cleared on May 15, 1998 after a 58-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: May 15, 1998
Review: 58 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK981000 Carrara Porcelain and Carrara Vincent PorcelainEuropean Dental Imports, Inc. · 1998
Descendant · cites it directly · 1 of its ownK040635 Carrara Interaction Ceramic SystemDentsply Intl. · 2004
Descendant · 2 generations on · 0 of its ownK070019 Carrara VolumiaDentsply Intl. · 2007

Most influential descendants

Showing 2 of 2 · See all

K040635Carrara Interaction Ceramic SystemDentsply Intl. · 2004 · cites it directly1descendant
K070019Carrara VolumiaDentsply Intl. · 2007 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K981000	Carrara Porcelain and Carrara Vincent Porcelain	European Dental Imports, Inc.	1998	—
+1	K040635	Carrara Interaction Ceramic System	Dentsply Intl.	2004	—
+2	K070019	Carrara Volumia	Dentsply Intl.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2007	1	0

FIG. 1 — Lineage of K981000, 1998–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

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
K040635	Carrara Interaction Ceramic System	Dentsply Intl.	2004	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?

Of its descendants, K040635 (Dentsply Intl., 2004) has gone furthest, with 1 descendant of its own.

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?

Used by a dental lab technician, under the direction of an attending dentist, to fashion and bake porcelain veneers onto dental alloy substrates so as to create the porcelain-fused-to-metal elements of a fixed or removable dental prosthesis.

Carrara Porcelain and Carrara Vincent Porcelain are recommended for use only with Carrara and Cera E dental alloys.

After fabrication and finishing, the completed prosthesis is approved and placed in the patient’s mouth by the dentist.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K981000 · printed Nov 5, 2026

Cite this page

510(k) Report. “K981000: Carrara Porcelain and Carrara Vincent Porcelain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981000

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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