Cleared Traditional

K031543 - STARCAST DENTAL ALLOYS

K031543 is an FDA 510(k) clearance for STARCAST DENTAL ALLOYS, manufactured by Star Refining Precious Metals South Africa. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K031543 · Star Refining Precious Metals South Africa · Dental device
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May 2003
Decision
14d
Days
Class 2
Risk

K031543 is an FDA 510(k) clearance for the STARCAST DENTAL ALLOYS. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Star Refining Precious Metals South Africa (Crofton, US). The FDA issued a Cleared decision on May 30, 2003 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Star Refining Precious Metals South Africa devices

FDA 510(k) Submission Details - K031543

510(k) Number K031543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2003
Decision Date May 30, 2003
Days to Decision 14 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 127d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

EJT Device Classification - Class 2, Special Controls

Product Code EJT Alloy, Gold-based Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EJT Alloy, Gold-based Noble Metal

All 550
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