Cleared Traditional

K903008 - VIDENT 90 ALLOY AND VIDENT 95 ALLOY

K903008 is an FDA 510(k) clearance for VIDENT 90 ALLOY AND VIDENT 95 ALLOY, manufactured by Vident. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K903008 · Vident · Dental device
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Sep 1990
Decision
57d
Days
Class 2
Risk

K903008 is an FDA 510(k) clearance for the VIDENT 90 ALLOY AND VIDENT 95 ALLOY. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Vident (Baldwin Park, US). The FDA issued a Cleared decision on September 6, 1990 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K903008

510(k) Number K903008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1990
Decision Date September 06, 1990
Days to Decision 57 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
71d faster than avg
Panel avg: 128d · This submission: 57d
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 152
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K903008.
(CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE
K901552 · Nobelpharma USA, Inc. · Jun 1991
THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST
K911821 · Dentecon, Inc. · May 1991
WIRON 99 DENTAL CASTING ALLOY
K903538 · Leach and Dillon Co., Inc. · Mar 1991
STELLITE COBALT/CHROMIUM BASE METAL ALLOY
K900117 · D.C. Dental Specialties · Apr 1990
TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)
K896501 · Leach and Dillon Co., Inc. · Feb 1990
TALLADIUM TILITE CERAMIC ALLOY
K894085 · Talladium, Inc. · Dec 1989
K903008 · VIDENT 90 ALLOY AND VIDENT 95 ALLOY
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