Cleared Traditional

K922790 - DEGUCAST 40

K922790 is an FDA 510(k) clearance for DEGUCAST 40, 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 177-day FDA review.

K922790 · Degussa AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
177d
Days
Class 2
Risk

K922790 is an FDA 510(k) clearance for the DEGUCAST 40. 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 December 3, 1992 after a review of 177 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 - K922790

510(k) Number K922790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1992
Decision Date December 03, 1992
Days to Decision 177 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 127d · This submission: 177d
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 K922790.
R1, R2, AND R1+
K922954 · Jeneric/Pentron, Inc. · Jul 1993
DUCERANIUM U
K926347 · Degussa AG · May 1993
VERASOFT CASTING ALLOY
K925579 · Aalba Dent, Inc. · Mar 1993
VERA PDS & VERA PDI
K915249 · Aalba Dent, Inc. · Mar 1992
DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET.
K920561 · Ivoclar North America, Inc. · Mar 1992
NPG III CASTING ALLOY
K915247 · Aalba Dent, Inc. · Dec 1991