Cleared Traditional

STAR ALLOYS, LITE ALLOYS AND BRITE ALLOYS (K882532) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K882532 · Five Stars Alloys , Ltd. · Dental device
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Oct 1988
Decision
120d
Days
Class 2
Risk

K882532 is an FDA 510(k) clearance for the STAR ALLOYS, LITE ALLOYS AND BRITE ALLOYS. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Five Stars Alloys , Ltd. (Cedarhurst, US). The FDA issued a Cleared decision on October 19, 1988 after a review of 120 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Five Stars Alloys , Ltd. devices

Submission Details

510(k) Number K882532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1988
Decision Date October 19, 1988
Days to Decision 120 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 127d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 210
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K882532.
ARGIPAL
K893011 · Argen Precious Metals, Inc. · May 1989
ARGEDENT 75
K892234 · Argen Precious Metals, Inc. · May 1989
ARGEDENT 52SF
K891911 · Argen Precious Metals, Inc. · May 1989
HOWMEDICA A-30 DENTAL ALLOY
K791304 · Howmedica Corp. · Oct 1979
A-33 DENTAL ALLOY
K781045 · Howmedica Corp. · Jul 1978
HERITAGE SPECIAL ALLOY
K771110 · Howmedica Corp. · Jul 1977