Cleared Traditional

DUALLOR R SOLDER (K844867) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844867 · Degussa Dental, Inc. · Dental device
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Mar 1985
Decision
101d
Days
Class 2
Risk

K844867 is an FDA 510(k) clearance for the DUALLOR R SOLDER. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Degussa Dental, Inc. (Long Island, US). The FDA issued a Cleared decision on March 25, 1985 after a review of 101 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 Degussa Dental, Inc. devices

Submission Details

510(k) Number K844867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1984
Decision Date March 25, 1985
Days to Decision 101 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 127d · This submission: 101d
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 210
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K844867.
ARGIPAL
K893011 · Argen Precious Metals, Inc. · May 1989
ARGEDENT 75
K892234 · Argen Precious Metals, Inc. · May 1989
ARGEDENT 52SF
K891911 · Argen Precious Metals, Inc. · May 1989
HOWMEDICA A-30 DENTAL ALLOY
K791304 · Howmedica Corp. · Oct 1979
A-33 DENTAL ALLOY
K781045 · Howmedica Corp. · Jul 1978
HERITAGE SPECIAL ALLOY
K771110 · Howmedica Corp. · Jul 1977