Cleared Traditional

HIGH FUSING WHITE CERAMIC SOLDER (K895058) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K895058 · Leach and Dillon Co., Inc. · Dental device
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Oct 1990
Decision
423d
Days
Class 2
Risk

K895058 is an FDA 510(k) clearance for the HIGH FUSING WHITE CERAMIC SOLDER. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Leach and Dillon Co., Inc. (Mansfield, US). The FDA issued a Cleared decision on October 5, 1990 after a review of 423 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Leach and Dillon Co., Inc. devices

Submission Details

510(k) Number K895058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date October 05, 1990
Days to Decision 423 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
296d slower than avg
Panel avg: 127d · This submission: 423d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJT Alloy, Gold-based Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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 - EJT Alloy, Gold-based Noble Metal

All 208
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K895058.
ARGENCO 52HN
K905811 · Argen Precious Metals, Inc. · Jan 1991
ARGENCO 19
K904437 · Argen Precious Metals, Inc. · Nov 1990
ARGENCO 22
K904343 · Argen Precious Metals, Inc. · Oct 1990
ARGENCO 8 GOLD ALLOY FOR PORCELAIN
K903678 · Argen Precious Metals, Inc. · Sep 1990
ARGIBOND DENTAL ALLOY FOR PORCELAIN
K903818 · Argen Precious Metals, Inc. · Sep 1990
ARGISTAR 45 GOLD ALLOY FOR PORCELAIN
K903819 · Argen Precious Metals, Inc. · Sep 1990