Cleared Traditional

K921419 - DEVA PLUS

K921419 is the FDA 510(k) clearance for DEVA PLUS by Degussa AG. It is a Class 2 Dental device (product code EJS) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K921419 · Degussa AG · Dental device
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May 1992
Decision
63d
Days
Class 2
Risk

K921419 is an FDA 510(k) clearance for the DEVA PLUS. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Degussa AG (South Plainfield, US). The FDA issued a Cleared decision on May 26, 1992 after a review of 63 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 Degussa AG devices

Submission Details

510(k) Number K921419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1992
Decision Date May 26, 1992
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
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 117
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K921419.
PA-400
K922449 · J.F. Jelenko & Co., Inc. · Aug 1992
BENCHMARK C
K922450 · J.F. Jelenko & Co., Inc. · Aug 1992
LEGACY-XT
K922451 · J.F. Jelenko & Co., Inc. · Aug 1992
DEGUBOND PLUS
K921445 · Degussa AG · May 1992
GDC 3367
K920922 · Deringer-Ney, Inc. · May 1992
ARGEBOND 77+
K915165 · Argen Precious Metals, Inc. · Apr 1992