Cleared Traditional

K905034 - HD-4 CROWN & BRIDGE ALLOY

K905034 is an FDA 510(k) clearance for HD-4 CROWN & BRIDGE ALLOY, manufactured by Ho Dental Co., Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K905034 · Ho Dental Co., Inc. · Dental device
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Sep 1991
Decision
302d
Days
Class 2
Risk

K905034 is an FDA 510(k) clearance for the HD-4 CROWN & BRIDGE ALLOY. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Ho Dental Co., Inc. (Wilmette, US). The FDA issued a Cleared decision on September 5, 1991 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Ho Dental Co., Inc. devices

FDA 510(k) Submission Details - K905034

510(k) Number K905034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1990
Decision Date September 05, 1991
Days to Decision 302 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 127d · This submission: 302d
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 100
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K905034.
NPG III CASTING ALLOY
K915247 · Aalba Dent, Inc. · Dec 1991
LPG CASTING ALLOY
K915248 · Aalba Dent, Inc. · Dec 1991
ROCATEC(R) -PLUS
K913857 · Espe GmbH (Us) · Dec 1991
(CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE
K901552 · Nobelpharma USA, Inc. · Jun 1991
WIRON 99 DENTAL CASTING ALLOY
K903538 · Leach and Dillon Co., Inc. · Mar 1991
VIDENT 90 ALLOY AND VIDENT 95 ALLOY
K903008 · Vident · Sep 1990