Cleared Traditional

K895054 - .650 FINE GOLD SOLDER

K895054 is the FDA 510(k) clearance for .650 FINE GOLD SOLDER by Leach and Dillon Co., Inc.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K895054 · Leach and Dillon Co., Inc. · Dental device
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Dec 1989
Decision
133d
Days
Class 2
Risk

K895054 is an FDA 510(k) clearance for the .650 FINE GOLD 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 December 19, 1989 after a review of 133 days - within the typical 510(k) review window.

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: 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 Leach and Dillon Co., Inc. devices

Submission Details

510(k) Number K895054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date December 19, 1989
Days to Decision 133 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 127d · This submission: 133d
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 435
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K895054.
MONOGRAM IV
K895066 · Leach and Dillon Co., Inc. · Feb 1990
ARGELITE 80 + 5 DENTAL ALLOY FOR PORCELAIN APPL.
K896348 · Argen Precious Metals, Inc. · Feb 1990
SEQUEL (CASTING ALLOY FOR PORCELAIN-FUSED-METAL)
K893800 · Deringer-Ney, Inc. · Dec 1989
LOW FUSING WHITE GOLD
K895056 · Leach and Dillon Co., Inc. · Dec 1989
750 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS
K895060 · Leach and Dillon Co., Inc. · Dec 1989
450 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS
K895063 · Leach and Dillon Co., Inc. · Dec 1989