Cleared Traditional

K964192 - ARDENT NON GAMMA-2 70

K964192 is an FDA 510(k) clearance for ARDENT NON GAMMA-2 70, manufactured by Ardent Production Development. The device is a Class 2 Dental device with product code EJJ cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K964192 · Ardent Production Development · Dental device
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Jan 1997
Decision
81d
Days
Class 2
Risk

K964192 is an FDA 510(k) clearance for the ARDENT NON GAMMA-2 70. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Ardent Production Development (Tonawanda, US). The FDA issued a Cleared decision on January 6, 1997 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ardent Production Development devices

FDA 510(k) Submission Details - K964192

510(k) Number K964192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1996
Decision Date January 06, 1997
Days to Decision 81 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 127d · This submission: 81d
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 45
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K964192.
CENTURY ALLOY
K974035 · Dentsply Intl. · Dec 1997
PLA-96P
K973086 · Southern Dental Industries, Inc. · Oct 1997
PLS-96P
K973088 · Southern Dental Industries, Inc. · Oct 1997
ARDENT FUTURA NON GAMMA-2
K964775 · Ardent Production Development · Dec 1996
GALLOY
K955285 · Southern Dental Industries, Inc. · Jan 1996
TYTIN R
K951663 · Kerr Corporation (Danbury) · Jun 1995