Cleared Traditional

K964573 - PIEDMONT 70 (CH-35)

K964573 is the FDA 510(k) clearance for PIEDMONT 70 (CH-35) by Gateway Alloys, Inc.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K964573 · Gateway Alloys, Inc. · Dental device
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Dec 1996
Decision
22d
Days
Class 2
Risk

K964573 is an FDA 510(k) clearance for the PIEDMONT 70 (CH-35). 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 December 6, 1996 after a review of 22 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 K964573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1996
Decision Date December 06, 1996
Days to Decision 22 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
105d faster than avg
Panel avg: 127d · This submission: 22d
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 K964573.
OZARK 46
K964568 · Gateway Alloys, Inc. · Dec 1996
EL DORADO 58
K964569 · Gateway Alloys, Inc. · Dec 1996
PALLADIA 76
K964572 · Gateway Alloys, Inc. · Dec 1996
DE ORO 77
K964476 · Gateway Alloys, Inc. · Dec 1996
OZARK 40
K964477 · Gateway Alloys, Inc. · Dec 1996
PACIFIC 52 (CB-39)
K964464 · Gateway Alloys, Inc. · Nov 1996