Cleared Traditional

K870230 - ALLOY FOR DENTAL AMALGAM LUXALLOY NON GAMMA 2

K870230 is an FDA 510(k) clearance for ALLOY FOR DENTAL AMALGAM LUXALLOY NON G..., manufactured by Degussa Dental, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K870230

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
Combination Product No
PCCP Authorized No
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.

EJJ Device Classification - Class 2, Special Controls

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 45
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
LIMI ALLOY
K844653 · G-C Intl. Corp. · Mar 1985
SPHEREX E.C.T.
K822951 · Jeneric Ind. · Oct 1982
VALULINE* AMALGAM ALLOY
K821971 · Johnson & Johnson Professionals, Inc. · Jul 1982