Cleared Traditional

K926347 - DUCERANIUM U

K926347 is an FDA 510(k) clearance for DUCERANIUM U, manufactured by Degussa AG. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K926347 · Degussa AG · Dental device
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May 1993
Decision
161d
Days
Class 2
Risk

K926347 is an FDA 510(k) clearance for the DUCERANIUM U. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Degussa AG (South Plainfield, US). The FDA issued a Cleared decision on May 27, 1993 after a review of 161 days - an extended review 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: 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 Degussa AG devices

FDA 510(k) Submission Details - K926347

510(k) Number K926347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1992
Decision Date May 27, 1993
Days to Decision 161 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
34d slower than avg
Panel avg: 127d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJH Device Classification - Class 2, Special Controls

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 99
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K926347.
ARGELOY N.P. (V) (NON-PRECIOUS DENTAL ALLOY FOR PROCELAIN APPLICATION)
K935972 · Argen Precious Metals, Inc. · Jan 1994
ARGELITE 81SF+
K934768 · Argen Precious Metals, Inc. · Dec 1993
R1, R2, AND R1+
K922954 · Jeneric/Pentron, Inc. · Jul 1993
VERASOFT CASTING ALLOY
K925579 · Aalba Dent, Inc. · Mar 1993
DEGUCAST 40
K922790 · Degussa AG · Dec 1992
VERA PDS & VERA PDI
K915249 · Aalba Dent, Inc. · Mar 1992