Cleared Traditional

K923640 - GK DENTAL AMALGAM ALLOY

K923640 is an FDA 510(k) clearance for GK DENTAL AMALGAM ALLOY, manufactured by The Patron Trading Corp.. The device is a Class 2 Dental device with product code EJJ cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K923640 · The Patron Trading Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
206d
Days
Class 2
Risk

K923640 is an FDA 510(k) clearance for the GK DENTAL AMALGAM ALLOY. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by The Patron Trading Corp. (Jackson Heights, US). The FDA issued a Cleared decision on February 12, 1993 after a review of 206 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3070 - 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 The Patron Trading Corp. devices

FDA 510(k) Submission Details - K923640

510(k) Number K923640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1992
Decision Date February 12, 1993
Days to Decision 206 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
79d slower than avg
Panel avg: 127d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJJ Device Classification - Class 2, Special Controls

Product Code EJJ Alloy, Amalgam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3070
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 - EJJ Alloy, Amalgam

All 46
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K923640.
TYTIN ADMIX
K951511 · Kerr Corporation (Danbury) · May 1995
SYBRALOY
K940675 · Sybron Dental Specialties, Inc. · Apr 1994
TYTIN
K935535 · Kerr Corporation (Danbury) · Mar 1994
MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES
K913175 · G-C Intl. Corp. · Dec 1991
DW 236
K905204 · Ivoclar North America, Inc. · Mar 1991
DW 235
K905205 · Ivoclar North America, Inc. · Dec 1990