Cleared Traditional

K912306 - STANDARD S4

K912306 is the FDA 510(k) clearance for STANDARD S4 by Metalor Dental USA Corp.. It is a Class 2 Dental device (product code EJS) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K912306 · Metalor Dental USA Corp. · Dental device
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Jun 1991
Decision
36d
Days
Class 2
Risk

K912306 is an FDA 510(k) clearance for the STANDARD S4. 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 June 26, 1991 after a review of 36 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 Metalor Dental USA Corp. devices

Submission Details

510(k) Number K912306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1991
Decision Date June 26, 1991
Days to Decision 36 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
91d faster than avg
Panel avg: 127d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 117
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K912306.
VS11
K912300 · Metalor Dental USA Corp. · Jun 1991
STANDARD S1
K912303 · Metalor Dental USA Corp. · Jun 1991
STANDARD S2
K912304 · Metalor Dental USA Corp. · Jun 1991
STANDARD S33
K912309 · Metalor Dental USA Corp. · Jun 1991
CERAPALL
K911670 · Metalor Dental USA Corp. · Jun 1991
MAXIBOND
K911757 · Argen Precious Metals, Inc. · Jun 1991