Cleared Traditional

K895068 - SELECT 50

K895068 is the FDA 510(k) clearance for SELECT 50 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 132-day FDA review.

K895068 · Leach and Dillon Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
132d
Days
Class 2
Risk

K895068 is an FDA 510(k) clearance for the SELECT 50. 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 18, 1989 after a review of 132 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 K895068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date December 18, 1989
Days to Decision 132 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
5d slower than avg
Panel avg: 127d · This submission: 132d
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 K895068.
500 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS
K895062 · Leach and Dillon Co., Inc. · Dec 1989
MONOGRAM II
K895064 · Leach and Dillon Co., Inc. · Dec 1989
MONOGRAM III
K895065 · Leach and Dillon Co., Inc. · Dec 1989
ARGENCO 50 TYPE IV TYPE IV DENTAL GOLD ALLOY
K893566 · Argen Precious Metals, Inc. · Jul 1989
ARGENCO 68 TYPE IV DENTAL GOLD ALLOY
K893565 · Argen Precious Metals, Inc. · Jun 1989
ARGENCO 56 TYPE IV DENTAL GOLD ALLOY
K893568 · Argen Precious Metals, Inc. · Jun 1989