Cleared Traditional

K870230 - ALLOY FOR DENTAL AMALGAM LUXALLOY NON G...

K870230 is the FDA 510(k) clearance for ALLOY FOR DENTAL AMALGAM LUXALLOY NON G... by Degussa Dental, Inc.. It is a Class 2 Dental device (product code EJJ) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K870230 · Degussa Dental, Inc. · Dental device
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May 1987
Decision
119d
Days
Class 2
Risk

K870230 is an FDA 510(k) clearance for the ALLOY FOR DENTAL AMALGAM LUXALLOY NON GAMMA 2. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Degussa Dental, Inc. (Long Island, US). The FDA issued a Cleared decision on May 20, 1987 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3070 - 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 Degussa Dental, Inc. devices

Submission Details

510(k) Number K870230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1987
Decision Date May 20, 1987
Days to Decision 119 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 127d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJJ Alloy, Amalgam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3070
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 - EJJ Alloy, Amalgam

All 24
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K870230.
OROSPHERE HCDP
K890681 · Jeneric/Pentron, Inc. · May 1989
OLYMPIA ALLOY
K881333 · J.F. Jelenko & Co., Inc. · Apr 1988
HERAEUS' HERAGAM 48, NON GAMMA 2 DEN. AMAL. ALLOY
K875344 · Kulzer, Inc. · Mar 1988
VALULINE* AMALGAM ALLOY
K821971 · Johnson & Johnson Professionals, Inc. · Jul 1982
A DENTAL AMALGAM ALLOY (UNNAMED
K820389 · Dentsply Intl. · Mar 1982
SYBRON/KERR CONTOUR
K820181 · Sybron Corp. · Feb 1982