Cleared Traditional

DW207 #28G, DW207 #35F, DW207 #39LC (K931365) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K931365 · Ivoclar North America, Inc. · Dental device
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Jun 1993
Decision
97d
Days
Class 2
Risk

K931365 is an FDA 510(k) clearance for the DW207 #28G, DW207 #35F, DW207 #39LC. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on June 22, 1993 after a review of 97 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 Ivoclar North America, Inc. devices

Submission Details

510(k) Number K931365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1993
Decision Date June 22, 1993
Days to Decision 97 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 127d · This submission: 97d
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 208
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K931365.
ARGELITE W
K934769 · Argen Precious Metals, Inc. · Nov 1993
ARGELITE 85
K931554 · Argen Precious Metals, Inc. · Jul 1993
ARGELITE 55
K931475 · Argen Precious Metals, Inc. · Jul 1993
ARGENCO 75M
K924241 · Argen Precious Metals, Inc. · Nov 1992
ULTRACROWN(TM) PRE-SOLDER
K914186 · Dentsply Intl. · Dec 1991
TYPE III DENTAL GOLD ALLOY FOR CROWN & BRIDGE APP.
K905761 · Argen Precious Metals, Inc. · Jan 1991