Cleared Traditional

K920560 - DW236-34 ALLOY FOR PORCELAIN FUSED TO METAL

K920560 is an FDA 510(k) clearance for DW236-34 ALLOY FOR PORCELAIN FUSED TO METAL, manufactured by Invoclar North America, Inc.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K920560 · Invoclar North America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
25d
Days
Class 2
Risk

K920560 is an FDA 510(k) clearance for the DW236-34 ALLOY FOR PORCELAIN FUSED TO METAL. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Invoclar 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 872.3060 - 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: 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 Invoclar North America, Inc. devices

FDA 510(k) Submission Details - K920560

510(k) Number K920560 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
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.

EJS Device Classification - Class 2, Special Controls

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 172
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K920560.
ARGEBOND 77+
K915165 · Argen Precious Metals, Inc. · Apr 1992
DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL
K920613 · Ivoclar North America, Inc. · Apr 1992
GDC-3338, DENTAL SOLDER ALLOY
K920887 · Deringer-Ney, Inc. · Mar 1992
ARGEBOND 80
K913704 · Argen Precious Metals, Inc. · Nov 1991
ULTRACROWN(TM) PD ALLOY POST-SOLDER
K913860 · Dentsply Intl. · Nov 1991
PLATINUM FOIL PLATINUM MILING WAFER
K914627 · Metalor Dental USA Corp. · Nov 1991