Cleared Traditional

K844394 - RENAISSANCE BONDING AGENT

K844394 is an FDA 510(k) clearance for RENAISSANCE BONDING AGENT, manufactured by Williams Gold Refining Co., Inc.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K844394 · Williams Gold Refining Co., Inc. · Dental device
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Jan 1985
Decision
57d
Days
Class 2
Risk

K844394 is an FDA 510(k) clearance for the RENAISSANCE BONDING AGENT. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Williams Gold Refining Co., Inc. (Buffalo, US). The FDA issued a Cleared decision on January 9, 1985 after a review of 57 days - a notably fast clearance cycle.

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: 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 Williams Gold Refining Co., Inc. devices

FDA 510(k) Submission Details - K844394

510(k) Number K844394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1984
Decision Date January 09, 1985
Days to Decision 57 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
70d faster than avg
Panel avg: 127d · This submission: 57d
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 489
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K844394.
GDC 1824
K865049 · Deringer-Ney, Inc. · Mar 1987
VERINOR ALLOY
K864306 · Degussa Dental, Inc. · Nov 1986
DUALLOR R SOLDER
K844867 · Degussa Dental, Inc. · Mar 1985
RENAISSANCE
K844395 · Williams Gold Refining Co., Inc. · Jan 1985
RXG
K833052 · Jeneric Ind. · Nov 1983
Y CERAMIC
K833053 · Jeneric Ind. · Nov 1983