Cleared Traditional

K011659 - GPW-SF

K011659 is the FDA 510(k) clearance for GPW-SF by Gateway Alloys, Inc.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K011659 · Gateway Alloys, Inc. · Dental device
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Aug 2001
Decision
90d
Days
Class 2
Risk

K011659 is an FDA 510(k) clearance for the GPW-SF. 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Gateway Alloys, Inc. devices

Submission Details

510(k) Number K011659 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 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 K011659.
AUTOPAL 50
K021733 · Wieland Dental + Technik GmbH & Co. KG · Jun 2002
PORTALLOY 54
K021242 · Wieland Dental + Technik GmbH & Co. KG · May 2002
PORTADUR P 4
K020190 · Wieland Dental + Technik GmbH & Co. KG · Mar 2002
CONCORD 88
K011661 · Gateway Alloys, Inc. · Aug 2001
CONCORD 72
K011626 · Gateway Alloys, Inc. · Jul 2001
CONCORD 82
K011628 · Gateway Alloys, Inc. · Jul 2001