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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 128d · 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 Consultant

Entela, Inc.
N.E. DEVINE, JR.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EJT Alloy, Gold-based Noble Metal

All 626
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K031543.
STARBOND DENTAL BONDING ALLOYS
K032106 · Star Refining Precious Metals South Africa · Aug 2003
MIRACLE 98
K031010 · Sb Lucius, Inc. · Jun 2003
PORTA PRESSOVER
K031264 · Wieland Dental + Technik GmbH & Co. KG · Jun 2003
BIOUNIVERSAL PKF
K030435 · Ivoclar Vivadent, Inc. · Apr 2003
BIO UNIVERSAL
K030436 · Ivoclar Vivadent, Inc. · Apr 2003
PORTA IMPLANT
K030312 · Wieland Dental + Technik GmbH & Co. KG · Mar 2003
K031543 · STARCAST DENTAL ALLOYS
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