Cleared Traditional

K902863 - PALLADIUS-V AND PALLADIUS-AG SEMI-PRECIOUS ALLOY

K902863 is an FDA 510(k) clearance for PALLADIUS-V AND PALLADIUS-AG SEMI-PRECI..., manufactured by Vident. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K902863

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.

EJT Device Classification - Class 2, Special Controls

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 550
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
250 SL DENTAL CASTING ALLOY
K903537 · Leach and Dillon Co., Inc. · Oct 1990
HIGH FUSING WHITE CERAMIC SOLDER
K895058 · Leach and Dillon Co., Inc. · Oct 1990
HIGH FUSING YELLOW CERAMIC SOLDER
K895059 · Leach and Dillon Co., Inc. · Oct 1990