510(k) · Cleared

Cleared

Modification to: Cercon Base

K051462510(k) SpecialCleared Jun 24, 200521-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 Jun 24, 2005 as substantially equivalent to K013230 (Degussa - Ney Dental, Inc., 2001) after a 21-day review. Its family tree reaches back 1 generation to 2001. 191 later devices descend from it.

Decided: Jun 24, 2005
Review: 21 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K013230 (2001). 191 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK013230 Cercon BaseDegussa - Ney Dental, Inc. · 2001
This deviceK051462 Modification to: Cercon BaseDentsply Intl. · 2005
Descendant · cites it directly · 186 of its ownK072569 Metoxit Cam-BlanksMetoxit AG · 2007
Descendant · 2 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
Descendant · 3 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
Descendant · 3 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
Descendant · 4 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017

Showing 5 of 191 descendants. See all descendants

Descendants cleared per year

2007high 28 (2024) · low 1 (2007)2026

Most influential descendants

Showing 5 of 191 · See all

K072569Metoxit Cam-BlanksMetoxit AG · 2007 · cites it directly186descendants
K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 2 generations on165descendants
K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 3 generations on129descendants
K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 3 generations on89descendants
K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 4 generations on86descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K013230	Cercon Base	Degussa - Ney Dental, Inc.	2001	—
0 (this device)	K051462	Modification to: Cercon Base	Dentsply Intl.	2005	—
+1	K072569	Metoxit Cam-Blanks	Metoxit AG	2007	—
+2	K120822	Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN…	Institut Straumann AG	2012	—
+3	K150203	Medentika CAD/CAM Abutments	Medentika GmbH	2015	—
+3	K150367	Neodent Implant System	Jjgc Industria E Comercio DE Materiais Dentarios S	2015	—
+4	K170588	DESS Dental Smart Solutions	Terrats Medical SL	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	1	0
2010	1	0
2011	1	0
2012	2	0
2013	2	0
2014	3	0
2015	11	0
2016	7	0
2017	8	0
2018	12	0
2019	7	0
2020	12	0
2021	18	0
2022	15	0
2023	24	0
2024	28	0
2025	25	0
2026	12	0

FIG. 1 — Lineage of K051462, 2001–2026Source: 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

Get a 510(k) Report

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
*	K013230	Cercon Base Summary page 1 …ASE CLASS IFICATION NAME: Porcelain powder for clinical use, 872.6660 PREDICATE DEVICES: Cercon® Base, K0 13230 DEVICE DESCRIPTION: partially sintered yttria (yttrium oxide) CERC…	Degussa - Ney Dental, Inc.	2001	—

Also cleared against K013230: 14 other devices →

What descends from it? (191)

See all 191

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K072569	Metoxit Cam-Blanks	Metoxit AG	2007	186
K081263	Starceram	H.C. Starck Ceramics GmbH & Co.Kg	2008	17
K093748	DD Bio Z and DD Bio Z - Transpa	Dental Direkt of Amerika UG (Haftungsbeschraenkt)	2010	13
K112152	Cercon HT	Dentsply International, Inc.	2011	3
K160203	Adamant Zirconia Disc	Adamant Co., Ltd.	2016	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, K072569 (Metoxit AG, 2007) has gone furthest, with 186 descendants of its own.
14 other devices also cite its predicate K013230.

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?

CERCON® BASE is indicated for crowns, multi-unit bridges, and inlay bridges. Applications include both anterior and posterior regions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051462 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051462: Modification to: Cercon Base.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051462

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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