510(k) Report

510(k) · Cleared

Cleared

Gold Dental Casting Alloys

K033279510(k) TraditionalCleared Jan 15, 200497-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

Bego U.S.A. · EJT Alloy, Gold-Based Noble Metal

Cleared on Jan 15, 2004 after a 97-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Jan 15, 2004
Review
97 days
Class
Class II
Product code
EJT
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K033279Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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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?

No later submission names this one as a predicate yet.

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.

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

2011: 12014: 12016: 12017: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—01
20120—00
20130—00
20140—01
20150—00
20160—01
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

BegoStar is a precious dental casting alloy to make metal fised to ceramic dental restorations Pontorex G is a precious dental casting alloy to make crowr and bridgze dental restorations Platinlloyd KF is a precious dental casting alloy to make mretal futsed to ceramic dental restorations Bio Platiniloyd is a precious dental casting alloy to make metal fused to ceramic dental restorations Begopal S is a precious dental casting alloy to make metal fused…

Read the full statement (252 words)

BegoStar is a precious dental casting alloy to make metal fised to ceramic dental restorations

Pontorex G is a precious dental casting alloy to make crowr and bridgze dental restorations

Platinlloyd KF is a precious dental casting alloy to make mretal futsed to ceramic dental restorations

Bio Platiniloyd is a precious dental casting alloy to make metal fused to ceramic dental restorations

Begopal S is a precious dental casting alloy to make metal fused to ceramic dental restorations

Begorex 45 is a precious dental casting alloy to make metal fuised to ceramic dental restorations

PontoStar Ti is a precious dental casting alloy to make metal fuised to ceramic dental restorations

Pontolloyd G is a precious dental casting alloy to make mewa fused to ceramic dental restorations

Bio Pontostar XL is a precious dental casting alloy to make metal fused to ceramnic dental restorations

Begolloyd 60 is a precious dental casting alloy to make crown and bridge dental restorations

Begolloyd PF is a precious dental casting alloy to make crown and bridge dental restorations

PontoStar G is a precious dental casting alloy to make metal futsed to &eramic dental restorations

Gold EWL H is a precious dental casting alloy to make crown and bridge dental restorations

Platinfloyd M is a precious dental casting alloy to make crown and bridge dental restorations

Begopal 300 is a precious dental casting alloy to make metal fused to ceramic dental restorations

Begostar LFC is a precious dental casting alloy to make metal fused to ceramic dental restorations

Indications for use as stated in the FDA 510(k) statement.

Cite this page

510(k) Report. “K033279: Gold Dental Casting Alloys.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033279

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026