Cleared Traditional

K964940 - TAOS 28

K964940 is the FDA 510(k) clearance for TAOS 28 by Gateway Alloys, Inc.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K964940 · Gateway Alloys, Inc. · Dental device
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Jan 1997
Decision
34d
Days
Class 2
Risk

K964940 is an FDA 510(k) clearance for the TAOS 28. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Gateway Alloys, Inc. (St. Charles, US). The FDA issued a Cleared decision on January 13, 1997 after a review of 34 days - a notably fast clearance cycle.

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: 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 Gateway Alloys, Inc. devices

Submission Details

510(k) Number K964940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1996
Decision Date January 13, 1997
Days to Decision 34 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
93d faster than avg
Panel avg: 127d · This submission: 34d
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 435
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K964940.
TARGIS ALLOY #7
K970963 · Ivoclar North America, Inc. · Apr 1997
JELENKO NO.1 (CODE NAME RD-0601)
K970068 · J.F. Jelenko & Co., Inc. · Mar 1997
AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS)
K964772 · Ivoclar North America, Inc. · Jan 1997
EL DORADO 40
K964941 · Gateway Alloys, Inc. · Jan 1997
AURORA 52 (PM-01)
K964948 · Gateway Alloys, Inc. · Jan 1997
AURORA 53
K964949 · Gateway Alloys, Inc. · Jan 1997