Cleared Traditional

K844867 - DUALLOR R SOLDER

K844867 is an FDA 510(k) clearance for DUALLOR R SOLDER, manufactured by Degussa Dental, Inc.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 101-day FDA review.

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

FDA 510(k) Submission Details - K844867

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
Combination Product No
PCCP Authorized No
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.

EJT Device Classification - Class 2, Special Controls

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 551
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K844867.
PONTALLOR 4 DENTAL ALLOY
K870024 · Degussa Dental, Inc. · Mar 1987
GDC 1824
K865049 · Deringer-Ney, Inc. · Mar 1987
VERINOR ALLOY
K864306 · Degussa Dental, Inc. · Nov 1986
RENAISSANCE BONDING AGENT
K844394 · Williams Gold Refining Co., Inc. · Jan 1985
RENAISSANCE
K844395 · Williams Gold Refining Co., Inc. · Jan 1985
RXG
K833052 · Jeneric Ind. · Nov 1983