Cleared Traditional

K964466 - PALLADIA 75 (PM-11)

K964466 is an FDA 510(k) clearance for PALLADIA 75 (PM-11), manufactured by Gateway Alloys, Inc.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K964466 · Gateway Alloys, Inc. · Dental device
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Nov 1996
Decision
13d
Days
Class 2
Risk

K964466 is an FDA 510(k) clearance for the PALLADIA 75 (PM-11). 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 November 20, 1996 after a review of 13 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

FDA 510(k) Submission Details - K964466

510(k) Number K964466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1996
Decision Date November 20, 1996
Days to Decision 13 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
114d faster than avg
Panel avg: 127d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJT Device Classification - Class 2, Special Controls

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 551
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K964466.
PACIFIC 52 (CB-39)
K964464 · Gateway Alloys, Inc. · Nov 1996
LA PLATA 34 (PM-25)
K964465 · Gateway Alloys, Inc. · Nov 1996
OSAGE 76
K964478 · Gateway Alloys, Inc. · Nov 1996
QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015)
K962325 · Sterngold/Implamed · Jul 1996
STERNGOLD BIO-5 (1127210)
K962326 · Sterngold/Implamed · Jul 1996
PEGASUS DENTAL ALLOY
K962302 · Sterngold/Implamed · Jul 1996