Cleared Traditional

K896501 - TECH STAR DENTAL CASTING ALLOYS (NON-PR...

K896501 is the FDA 510(k) clearance for TECH STAR DENTAL CASTING ALLOYS (NON-PR... by Leach and Dillon Co., Inc.. It is a Class 2 Dental device (product code EJH) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K896501 · Leach and Dillon Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
87d
Days
Class 2
Risk

K896501 is an FDA 510(k) clearance for the TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS). Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Leach and Dillon Co., Inc. (Mansfield, US). The FDA issued a Cleared decision on February 9, 1990 after a review of 87 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 Leach and Dillon Co., Inc. devices

Submission Details

510(k) Number K896501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1989
Decision Date February 09, 1990
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 36
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K896501.
(CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE
K901552 · Nobelpharma USA, Inc. · Jun 1991
WIRON 99 DENTAL CASTING ALLOY
K903538 · Leach and Dillon Co., Inc. · Mar 1991
VIDENT 90 ALLOY AND VIDENT 95 ALLOY
K903008 · Vident · Sep 1990
RX ASPEN
K882170 · Jeneric/Pentron, Inc. · Jun 1988
PARTIAL DENTURE ALLOY
K860437 · Dentsply Intl. · Mar 1986
GDC 1453 CASTING ALLOY
K854285 · Deringer-Ney, Inc. · Dec 1985