Cleared Traditional

K902863 - PALLADIUS-V AND PALLADIUS-AG SEMI-PRECI...

K902863 is the FDA 510(k) clearance for PALLADIUS-V AND PALLADIUS-AG SEMI-PRECI... by Vident. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K902863 · Vident · Dental device
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Oct 1990
Decision
118d
Days
Class 2
Risk

K902863 is an FDA 510(k) clearance for the PALLADIUS-V AND PALLADIUS-AG SEMI-PRECIOUS ALLOY. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Vident (Baldwin Park, US). The FDA issued a Cleared decision on October 24, 1990 after a review of 118 days - within the typical 510(k) review window.

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: 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 Vident devices

Submission Details

510(k) Number K902863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1990
Decision Date October 24, 1990
Days to Decision 118 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 127d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJT Alloy, Gold-based 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 - EJT Alloy, Gold-based Noble Metal

All 377
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K902863.
GDC-1475
K904614 · Deringer-Ney, Inc. · Dec 1990
ARGENCO 19
K904437 · Argen Precious Metals, Inc. · Nov 1990
ARGENCO 22
K904343 · Argen Precious Metals, Inc. · Oct 1990
ARGENCO 8 GOLD ALLOY FOR PORCELAIN
K903678 · Argen Precious Metals, Inc. · Sep 1990
ARGIBOND DENTAL ALLOY FOR PORCELAIN
K903818 · Argen Precious Metals, Inc. · Sep 1990
ARGISTAR 45 GOLD ALLOY FOR PORCELAIN
K903819 · Argen Precious Metals, Inc. · Sep 1990