510(k) · Cleared

Cleared

Porta Geo TI

K023389510(k) TraditionalCleared Dec 6, 200258-day reviewClass II21 CFR 872.3060

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

Wieland Dental + Technik GmbH & Co. KG · EJT Alloy, Gold-Based Noble Metal

Cleared on Dec 6, 2002 as substantially equivalent to K935507 (Argen Precious Metals, Inc., 1994) after a 58-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided: Dec 6, 2002
Review: 58 days
Class: Class II
Product code: EJT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K935507 (1994). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK935507 Argedent 77PFArgen Precious Metals, Inc. · 1994
This deviceK023389 Porta Geo TIWieland Dental + Technik GmbH & Co. KG · 2002
Descendant · cites it directly · 0 of its ownK040672 Porta ReflexWieland Dental + Technik GmbH & Co. KG · 2004

Most influential descendants

Showing 1 of 1 · See all

K040672Porta ReflexWieland Dental + Technik GmbH & Co. KG · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K935507	Argedent 77PF	Argen Precious Metals, Inc.	1994	—
0 (this device)	K023389	Porta Geo TI	Wieland Dental + Technik GmbH & Co. KG	2002	—
+1	K040672	Porta Reflex	Wieland Dental + Technik GmbH & Co. KG	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K023389, 1994–2004Source: 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 EJT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	K935507	Argedent 77PF Summary page 1 …EJT C.D.R section: 872.3060 Classification: Class II Legally marketed equivalent device: Argedent 77PF 510(k) number: K 935507 Device description Porta Geo Ti is an extra-hard gold-platinum ceramic alloy with high contents of noble metals (95,4%), inte…	Argen Precious Metals, Inc.	1994	—

Also cleared against K935507: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K040672	Porta Reflex	Wieland Dental + Technik GmbH & Co. KG	2004	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, K040672 (Wieland Dental + Technik GmbH & Co. KG, 2004) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K935507.

How does its category compare?

All EJT devices

EJT Alloy, Gold-Based Noble Metal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EJT

FDA has decided no EJT device since 2007.

Median 510(k) review, days · EJT

Too few EJT 510(k)s in any year since 2007 to give a median.

Recalls per year · EJT

No recall names EJT since 2007.

Adverse event reports per year · EJT

1in 2017

2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code EJT, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	1
2012	—	0
2013	—	0
2014	—	1
2015	—	0
2016	—	1
2017	—	1
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

Porta Geo Ti is a gold-platinum alloy that can be used by dental technicians to fabricate dental appliances for patients.

It is intended for manufacturing

Inlays/ Onlays

Partial crowns

Crowns

Short span bridges

Long span bridges

Removable partials

and can be used for

Telescopic and milling work

Porta Geo Ti can be veneered with suitable dental ceramics as well as with dental-composites.

In addition Porta Geo Ti in the shape of wires, can be used for laser welding in operations in which dental alloy parts made of Porta Geo Ti are joined to form dental restorations.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023389 · printed Nov 4, 2026

Cite this page

510(k) Report. “K023389: Porta Geo TI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023389

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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