Cleared Traditional

K811563 - PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYS

K811563 is an FDA 510(k) clearance for PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYS, manufactured by Williams Gold Refining Co., Inc.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K811563 · Williams Gold Refining Co., Inc. · Dental device
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Jul 1981
Decision
54d
Days
Class 2
Risk

K811563 is an FDA 510(k) clearance for the PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYS. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Williams Gold Refining Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1981 after a review of 54 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 - K811563

510(k) Number K811563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1981
Decision Date July 28, 1981
Days to Decision 54 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
73d faster than avg
Panel avg: 127d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJS Device Classification - Class 2, Special Controls

Product Code EJS Alloy, Other 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 - EJS Alloy, Other Noble Metal

All 156
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K811563.
CLASS OF CASTING ALLOYS TYPE IV OR ALT
K820408 · Howmedica Corp. · Mar 1982
INZOMA NP
K813418 · J. Aderer, Inc. · Jan 1982
BAK-ON SP PORCELAIN ALLOY
K812101 · Johnson & Johnson Professionals, Inc. · Aug 1981
HOWMEDICA T-III G ALLOY
K810380 · Howmedica Corp. · Mar 1981
GDC 934
K801277 · Deringer-Ney, Inc. · Jul 1980
AUSTRY ALLOY(DENTAL BAKE-ON ALLOY)
K800994 · Howmedica Corp. · May 1980