510(k) · Cleared

Cleared

Metoxit Cam-Blanks

K072569510(k) TraditionalCleared Oct 31, 200749-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

Metoxit AG · EIH Powder, Porcelain

Cleared on Oct 31, 2007 as substantially equivalent to K013230 (Degussa - Ney Dental, Inc., 2001) and 7 other predicates after a 49-day review. Its family tree reaches back 2 generations to 2001. 186 later devices descend from it.

Decided: Oct 31, 2007
Review: 49 days
Class: Class II
Product code: EIH
Recalls: None
Predicates: 8

Its longest line of descent runs back 2 generations to K013230 (2001). 8 ancestors in all, the oldest K001815 (2000). 186 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 2 generations backK013230 Cercon BaseDegussa - Ney Dental, Inc. · 2001
1 generation backK050903 Xawex G 100Wieland Dental + Technik GmbH & Co. KG · 2005
This deviceK072569 Metoxit Cam-BlanksMetoxit AG · 2007
Descendant · cites it directly · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
Descendant · 2 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
Descendant · 2 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
Descendant · 3 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
Descendant · 4 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018

Showing 5 of 186 descendants. See all descendants

Descendants cleared per year

2008high 27 (2024) · low 0 (2011)2026

Most influential descendants

Showing 5 of 186 · See all

K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · cites it directly165descendants
K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 2 generations on129descendants
K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 2 generations on89descendants
K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 3 generations on86descendants
K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 4 generations on51descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K013230	Cercon Base	Degussa - Ney Dental, Inc.	2001	—
−1	K050903	Xawex G 100	Wieland Dental + Technik GmbH & Co. KG	2005	—
0 (this device)	K072569	Metoxit Cam-Blanks	Metoxit AG	2007	—
+1	K120822	Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN…	Institut Straumann AG	2012	—
+2	K150203	Medentika CAD/CAM Abutments	Medentika GmbH	2015	—
+2	K150367	Neodent Implant System	Jjgc Industria E Comercio DE Materiais Dentarios S	2015	—
+3	K170588	DESS Dental Smart Solutions	Terrats Medical SL	2017	—
+4	K173908	DESS Dental Smart Solutions	Terrats Medical SL	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2002	1	0
2005	3	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	1	0
2010	1	0
2012	2	0
2013	1	0
2014	3	0
2015	11	0
2016	6	0
2017	8	0
2018	12	0
2019	7	0
2020	12	0
2021	18	0
2022	15	0
2023	24	0
2024	27	0
2025	25	0
2026	12	0

FIG. 1 — Lineage of K072569, 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? (8)

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 …Metoxit CAM-Blanks Device common name: CAM-Blanks Device classification name: Porcelain Powder for Clinical Use Legally marketed devices K013230, K051462 - Cercon base to which the device is K051462 Cercon base colored substantially equivalent: K050903 XAWEX…	Degussa - Ney Dental, Inc.	2001	—
*	K051462	Modification to: Cercon Base Summary page 1 …toxit CAM-Blanks Device common name: CAM-Blanks Device classification name: Porcelain Powder for Clinical Use Legally marketed devices K013230, K051462 - Cercon base to which the device is K051462 Cercon base colored substantially equivalent: K050903 XAWEX G100…	Dentsply Intl.	2005	—
*	K050903	Xawex G 100 Summary page 1 …Clinical Use Legally marketed devices K013230, K051462 - Cercon base to which the device is K051462 Cercon base colored substantially equivalent: K050903 XAWEX G100 K022996 Vita YZ cubes K051705 Ivoclar ZIRCAD…	Wieland Dental + Technik GmbH & Co. KG	2005	—
*	K022996	Vita in-Ceram YZ Cubes for Cerec Summary page 1 …230, K051462 - Cercon base to which the device is K051462 Cercon base colored substantially equivalent: K050903 XAWEX G100 K022996 Vita YZ cubes K051705 Ivoclar ZIRCAD K052130 Vita AL cubes…	Vident	2002	—
*	K051705	Ips E.Max Cad/Ips E.Max Zircad Summary page 1 …K051462 Cercon base colored substantially equivalent: K050903 XAWEX G100 K022996 Vita YZ cubes K051705 Ivoclar ZIRCAD K052130 Vita AL cubes K062506 Sirona InCoris AL…	Ivoclar Vivadent, Inc.	2005	10
*	K052130	Vita in-Ceram 2000 AL Cubes for Inlab, Models AL20/AL40 Summary page 1 …nt: K050903 XAWEX G100 K022996 Vita YZ cubes K051705 Ivoclar ZIRCAD K052130 Vita AL cubes K062506 Sirona InCoris AL K001815 DCS DC-Zirkon De…	Vident	2005	—
*	K062506	Incoris AL Summary page 1 …K022996 Vita YZ cubes K051705 Ivoclar ZIRCAD K052130 Vita AL cubes K062506 Sirona InCoris AL K001815 DCS DC-Zirkon Description of the device: Metoxit CAM-Blanks are d…	Sirona Dental Systems GmbH	2006	—
*	K001815	DC Zirkon Summary page 1 …K051705 Ivoclar ZIRCAD K052130 Vita AL cubes K062506 Sirona InCoris AL K001815 DCS DC-Zirkon Description of the device: Metoxit CAM-Blanks are dental ceramics, composed of yttrium-oxide…	Austenal, Inc.	2000	—

Also cleared against K013230: 14 other devices →

What descends from it? (186)

See all 186

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

Number	Device	Applicant	Decided	Descendants
K120822	Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…	Institut Straumann AG	2012	165
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
K222836	Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs	Institut Straumann AG	2023	0
K173971	K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent	Yeti Dentalprodukte GmbH	2018	0
K082137	DLMS-Zirblocks	Dental Milling Laboratory Supplies (Dlms)	2009	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?

The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
1 of the 8 ancestors has a recall of any class.
Of its descendants, K120822 (Institut Straumann AG, 2012) has gone furthest, with 165 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. 2007, this device’s year, is highlighted.

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?

Metoxit blanks are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations. Limitations are listed in Table 1. Table 1: Indications of use and maximum number of pontics. Process chain Material Single unit crowns Bridges, number of pontics Anterior Posterior Anterior Posterior Porous blank is TZPA X 2 2 machined to enlarged framework, then AI-99S X 1 sintered and veneered. Dense blank is TZP X 2 2 machined to net-shape…

Read the full statement (117 words)

Metoxit blanks are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations.

Limitations are listed in Table 1.

Table 1: Indications of use and maximum number of pontics.

Process chain Material Single unit crowns Bridges, number of pontics

Anterior Posterior Anterior Posterior

Porous blank is TZPA X 2 2

machined to

enlarged

framework, then AI-99S X 1

sintered and

veneered.

Dense blank is TZP X 2 2

machined to

net-shape

framework, then TZP-A X X 2 2

veneered.

X indicated; - not indicated; digits show maximum number of pontics.

All blanks are solely by or on the order of a dental professional. They are not for use by the general public or over-the-counter.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072569 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072569: Metoxit Cam-Blanks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072569

Report an extraction error

Are you the manufacturer?

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