Cleared Traditional

K933563 - VS 1A

K933563 is an FDA 510(k) clearance for VS 1A, manufactured by Metalor Dental USA Corp.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K933563 · Metalor Dental USA Corp. · Dental device
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Oct 1993
Decision
90d
Days
Class 2
Risk

K933563 is an FDA 510(k) clearance for the VS 1A. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Metalor Dental USA Corp. (Rockville Centre, US). The FDA issued a Cleared decision on October 20, 1993 after a review of 90 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 Metalor Dental USA Corp. devices

FDA 510(k) Submission Details - K933563

510(k) Number K933563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1993
Decision Date October 20, 1993
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
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 171
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K933563.
STERNGOLD G-HARD METAL ALLOY
K962301 · The Stern Metals Co., Inc. · Jul 1996
CU-FREE & LTA
K934757 · Jeneric/Pentron, Inc. · Feb 1994
ARGELITE A
K934773 · Argen Precious Metals, Inc. · Dec 1993
CORRECT AND CORRECT FIT II
K925331 · Jeneric/Pentron, Inc. · May 1993
BIO C & B
K926146 · Jeneric/Pentron, Inc. · May 1993
GOLD-PLATINUM BASED CASTING ALLOY
K926147 · Jeneric/Pentron, Inc. · May 1993