Cleared Traditional

GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO (K932243) - FDA 510(k) Clearance

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

K932243 · Precious Chemicals U.S.A., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
356d
Days
Class 2
Risk

K932243 is an FDA 510(k) clearance for the GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Precious Chemicals U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on April 28, 1994 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Precious Chemicals U.S.A., Inc. devices

Submission Details

510(k) Number K932243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1993
Decision Date April 28, 1994
Days to Decision 356 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
229d slower than avg
Panel avg: 127d · This submission: 356d
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 208
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K932243.
AUROLITE CB
K941067 · Argen Precious Metals, Inc. · Apr 1994
AURIUM PC16
K941072 · Argen Precious Metals, Inc. · Apr 1994
AURIUM D16
K941097 · Argen Precious Metals, Inc. · Apr 1994
AUROLITE CB80
K941068 · Argen Precious Metals, Inc. · Apr 1994
AUROLITE MT1
K941069 · Argen Precious Metals, Inc. · Apr 1994
AUROLITE CB+2
K941070 · Argen Precious Metals, Inc. · Apr 1994