Cleared Traditional

K850084 - TRINDIUM-DENTAL MATERIAL

K850084 is an FDA 510(k) clearance for TRINDIUM-DENTAL MATERIAL, manufactured by Trindium Corp. of America. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K850084 · Trindium Corp. of America · Dental device
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Jul 1985
Decision
179d
Days
Class 2
Risk

K850084 is an FDA 510(k) clearance for the TRINDIUM-DENTAL MATERIAL. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Trindium Corp. of America (Utica, US). The FDA issued a Cleared decision on July 8, 1985 after a review of 179 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 Trindium Corp. of America devices

FDA 510(k) Submission Details - K850084

510(k) Number K850084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1985
Decision Date July 08, 1985
Days to Decision 179 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 128d · This submission: 179d
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 103
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K850084.
H40 BASE METAL ALLOY
K854878 · Jeneric Ind. · Jan 1986
GDC 1453 CASTING ALLOY
K854285 · Deringer-Ney, Inc. · Dec 1985
CERAMIC ALLOY NO. DW 179
K852895 · Williams Gold Refining Co., Inc. · Oct 1985
VERA BOND NON PERCIOUS CERAMIC ALLOY
K851569 · Aalba Dent, Inc. · May 1985
AUSTENAL A-79 CROWN & BRIDGE CASTING ALLOY
K844497 · Austenal Dental, Inc. · Feb 1985
RX CBG
K844122 · Jeneric Ind. · Jan 1985