Cleared Abbreviated

CONCORD 82 (K011628) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K011628 · Gateway Alloys, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
48d
Days
Class 2
Risk

K011628 is an FDA 510(k) clearance for the CONCORD 82. 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 July 16, 2001 after a review of 48 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Gateway Alloys, Inc. devices

Submission Details

510(k) Number K011628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2001
Decision Date July 16, 2001
Days to Decision 48 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 127d · This submission: 48d
Pathway characteristics
Standards-based clearance path.

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 208
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K011628.
ORION E ALLOY
K032316 · Dentsply Intl. · Sep 2003
ORION GX ALLOY
K032317 · Dentsply Intl. · Sep 2003
285 SL
K961352 · Argen Precious Metals, Inc. · May 1996
ARGELITE 52+
K961211 · Argen Precious Metals, Inc. · Apr 1996
ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION)
K961285 · Argen Precious Metals, Inc. · Apr 1996
ARGISTAR 74
K954362 · Argen Precious Metals, Inc. · Oct 1995