Cleared Traditional

GDC 3509 (K933178) - FDA 510(k) Clearance

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

K933178 · Deringer-Ney, Inc. · Dental device
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Oct 1993
Decision
106d
Days
Class 2
Risk

K933178 is an FDA 510(k) clearance for the GDC 3509. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Deringer-Ney, Inc. (Bloomfield, US). The FDA issued a Cleared decision on October 14, 1993 after a review of 106 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 Deringer-Ney, Inc. devices

Submission Details

510(k) Number K933178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1993
Decision Date October 14, 1993
Days to Decision 106 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
21d faster than avg
Panel avg: 127d · This submission: 106d
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 K933178.
ARGENCO Y +
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ARGENCO M
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ARGELITE W
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ARGELITE 85
K931554 · Argen Precious Metals, Inc. · Jul 1993
ARGELITE 55
K931475 · Argen Precious Metals, Inc. · Jul 1993
ARGENCO 75M
K924241 · Argen Precious Metals, Inc. · Nov 1992