Cleared Traditional

K920561 - DW242-07 NON-PRECIOUS ALLOY F/ PORCELAI...

K920561 is the FDA 510(k) clearance for DW242-07 NON-PRECIOUS ALLOY F/ PORCELAI... by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EJH) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K920561 · Ivoclar North America, Inc. · Dental device
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Mar 1992
Decision
25d
Days
Class 2
Risk

K920561 is an FDA 510(k) clearance for the DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET.. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on March 2, 1992 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ivoclar North America, Inc. devices

Submission Details

510(k) Number K920561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1992
Decision Date March 02, 1992
Days to Decision 25 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
102d faster than avg
Panel avg: 127d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 35
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K920561.
R1, R2, AND R1+
K922954 · Jeneric/Pentron, Inc. · Jul 1993
DUCERANIUM U
K926347 · Degussa AG · May 1993
DEGUCAST 40
K922790 · Degussa AG · Dec 1992
ROCATEC(R) -PLUS
K913857 · Espe GmbH (Us) · Dec 1991
(CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE
K901552 · Nobelpharma USA, Inc. · Jun 1991
WIRON 99 DENTAL CASTING ALLOY
K903538 · Leach and Dillon Co., Inc. · Mar 1991