Cleared Abbreviated

K011661 - CONCORD 88

K011661 is the FDA 510(k) clearance for CONCORD 88 by Gateway Alloys, Inc.. It is a Class 2 Dental device (product code EJT) cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K011661 · Gateway Alloys, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
90d
Days
Class 2
Risk

K011661 is an FDA 510(k) clearance for the CONCORD 88. 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 August 27, 2001 after a review of 90 days - within the typical 510(k) review window.

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 K011661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2001
Decision Date August 27, 2001
Days to Decision 90 days
Submission Type Abbreviated
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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 435
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K011661.
PORTALLOY 54
K021242 · Wieland Dental + Technik GmbH & Co. KG · May 2002
PORTADUR P 4
K020190 · Wieland Dental + Technik GmbH & Co. KG · Mar 2002
GPW-SF
K011659 · Gateway Alloys, Inc. · Aug 2001
CONCORD 72
K011626 · Gateway Alloys, Inc. · Jul 2001
CONCORD 82
K011628 · Gateway Alloys, Inc. · Jul 2001
JP CAST 50
K011330 · Jeneric/Pentron, Inc. · Jun 2001