Cleared Traditional

K895054 - .650 FINE GOLD SOLDER

K895054 is an FDA 510(k) clearance for .650 FINE GOLD SOLDER, manufactured by Leach and Dillon Co., Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K895054

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.

EJT Device Classification - Class 2, Special Controls

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 551
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