Cleared Traditional

K894085 - TALLADIUM TILITE CERAMIC ALLOY

K894085 is an FDA 510(k) clearance for TALLADIUM TILITE CERAMIC ALLOY, manufactured by Talladium, Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K894085 · Talladium, Inc. · Dental device
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Dec 1989
Decision
195d
Days
Class 2
Risk

K894085 is an FDA 510(k) clearance for the TALLADIUM TILITE CERAMIC ALLOY. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Talladium, Inc. (Valencia, US). The FDA issued a Cleared decision on December 20, 1989 after a review of 195 days - an extended review 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: 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 Talladium, Inc. devices

FDA 510(k) Submission Details - K894085

510(k) Number K894085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1989
Decision Date December 20, 1989
Days to Decision 195 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 127d · This submission: 195d
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 K894085.
WIRON 99 DENTAL CASTING ALLOY
K903538 · Leach and Dillon Co., Inc. · Mar 1991
VIDENT 90 ALLOY AND VIDENT 95 ALLOY
K903008 · Vident · Sep 1990
TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)
K896501 · Leach and Dillon Co., Inc. · Feb 1990
RX ASPEN
K882170 · Jeneric/Pentron, Inc. · Jun 1988
VITALLIUM EQUIPOISE ALLOY
K880875 · Austenal Dental, Inc. · Apr 1988
A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY)
K864826 · Austenal Dental, Inc. · Feb 1987