Cleared Traditional

K853982 - GOLDEN CERAMIC

K853982 is an FDA 510(k) clearance for GOLDEN CERAMIC, manufactured by Wiliams 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 41-day FDA review.

K853982 · Wiliams Gold Refining Co., Inc. · Dental device
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Nov 1985
Decision
41d
Days
Class 2
Risk

K853982 is an FDA 510(k) clearance for the GOLDEN CERAMIC. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Wiliams Gold Refining Co., Inc. (Buffalo, US). The FDA issued a Cleared decision on November 7, 1985 after a review of 41 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 Wiliams Gold Refining Co., Inc. devices

FDA 510(k) Submission Details - K853982

510(k) Number K853982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1985
Decision Date November 07, 1985
Days to Decision 41 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 128d · This submission: 41d
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 553
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K853982.
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
DUALLOR R SOLDER
K844867 · Degussa Dental, Inc. · Mar 1985
RENAISSANCE BONDING AGENT
K844394 · Williams Gold Refining Co., Inc. · Jan 1985
RENAISSANCE
K844395 · Williams Gold Refining Co., Inc. · Jan 1985