Cleared Traditional

K923644 - DW243-64

K923644 is the FDA 510(k) clearance for DW243-64 by Ivoclar USA, Inc.. It is a Class 2 Dental device (product code EJS) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K923644 · Ivoclar USA, Inc. · Dental device
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Nov 1992
Decision
106d
Days
Class 2
Risk

K923644 is an FDA 510(k) clearance for the DW243-64. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Ivoclar USA, Inc. (Amherst, US). The FDA issued a Cleared decision on November 4, 1992 after a review of 106 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 USA, Inc. devices

Submission Details

510(k) Number K923644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1992
Decision Date November 04, 1992
Days to Decision 106 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
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJS Alloy, Other 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 - EJS Alloy, Other Noble Metal

All 118
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K923644.
KB58-KF
K922958 · Jeneric/Pentron, Inc. · Feb 1993
ZENON PLUS
K922955 · Jeneric/Pentron, Inc. · Dec 1992
GDC 3445
K925273 · Deringer-Ney, Inc. · Dec 1992
KB40-KF
K922956 · Jeneric/Pentron, Inc. · Sep 1992
PARAGON
K922957 · Jeneric/Pentron, Inc. · Sep 1992
ACCU-STAR
K922446 · J.F. Jelenko & Co., Inc. · Aug 1992