Cleared Traditional

K780642 - LITECAST SOLDER

K780642 is an FDA 510(k) clearance for LITECAST SOLDER, manufactured by Williams Gold Refining Co., Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K780642 · Williams Gold Refining Co., Inc. · Dental device
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May 1978
Decision
16d
Days
Class 2
Risk

K780642 is an FDA 510(k) clearance for the LITECAST SOLDER. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Williams Gold Refining Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on May 3, 1978 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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 - K780642

510(k) Number K780642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1978
Decision Date May 03, 1978
Days to Decision 16 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
111d faster than avg
Panel avg: 127d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJH Device Classification - Class 2, Special Controls

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 79
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K780642.
BA-93
K811407 · Deringer-Ney, Inc. · Jun 1981
CRYSTALLOY-P
K810594 · Shofu Dental Corp. · Mar 1981
WILL CERAM LITE-CAST B
K800371 · Williams Gold Refining Co., Inc. · Feb 1980
CROWN & BRIDGE ALLOY
K772256 · Johnson & Johnson Professionals, Inc. · Jan 1978
LITECAST CERAMIC
K771081 · Williams Gold Refining Co., Inc. · Jun 1977