Cleared Traditional

K860437 - PARTIAL DENTURE ALLOY

K860437 is the FDA 510(k) clearance for PARTIAL DENTURE ALLOY by Dentsply Intl.. It is a Class 2 Dental device (product code EJH) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K860437 · Dentsply Intl. · Dental device
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Mar 1986
Decision
41d
Days
Class 2
Risk

K860437 is an FDA 510(k) clearance for the PARTIAL DENTURE ALLOY. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on March 17, 1986 after a review of 41 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 Dentsply Intl. devices

Submission Details

510(k) Number K860437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1986
Decision Date March 17, 1986
Days to Decision 41 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
86d faster than avg
Panel avg: 127d · This submission: 41d
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 K860437.
VIDENT 90 ALLOY AND VIDENT 95 ALLOY
K903008 · Vident · Sep 1990
TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)
K896501 · Leach and Dillon Co., Inc. · Feb 1990
RX ASPEN
K882170 · Jeneric/Pentron, Inc. · Jun 1988
GDC 1453 CASTING ALLOY
K854285 · Deringer-Ney, Inc. · Dec 1985
BASE METAL ALLOY
K842551 · Dentsply Intl. · Aug 1984
PARTIAL DENTURE ALLOY
K833512 · Dentsply Intl. · Dec 1983