Cleared Traditional

K882532 - STAR ALLOYS, LITE ALLOYS AND BRITE ALLOYS

K882532 is an FDA 510(k) clearance for STAR ALLOYS, manufactured by Five Stars Alloys , Ltd.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K882532 · Five Stars Alloys , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K882532

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
8d faster than avg
Panel avg: 128d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 553
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K882532.
M-56 GOLD BASE DENTAL ALLOY
K891526 · Macdonald Metals and Ceramics · Apr 1989
ULTIMA LITE
K890568 · Deringer-Ney, Inc. · Mar 1989
NEYORO 65CF
K890569 · Deringer-Ney, Inc. · Mar 1989
ALBABOND 60
K883758 · Degussa Dental, Inc. · Oct 1988
HERA H
K883508 · Degussa Dental, Inc. · Sep 1988
PALLIAG NF III
K883036 · Degussa Dental, Inc. · Aug 1988