Cleared Traditional

K884257 - LEVINIUM

K884257 is an FDA 510(k) clearance for LEVINIUM, manufactured by Ticomet Engineering & Consulting. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K884257 · Ticomet Engineering & Consulting · Dental device
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Dec 1988
Decision
72d
Days
Class 2
Risk

K884257 is an FDA 510(k) clearance for the LEVINIUM. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Ticomet Engineering & Consulting (Cincinnati, US). The FDA issued a Cleared decision on December 22, 1988 after a review of 72 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.

View all Ticomet Engineering & Consulting devices

FDA 510(k) Submission Details - K884257

510(k) Number K884257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1988
Decision Date December 22, 1988
Days to Decision 72 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 128d · This submission: 72d
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 101
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K884257.
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