Cleared Traditional

VS11 SF (K951271) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K951271 · Metalor Dental USA Corp. · Dental device
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Jun 1995
Decision
93d
Days
Class 2
Risk

K951271 is an FDA 510(k) clearance for the VS11 SF. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Metalor Dental USA Corp. (Rockville Centre, US). The FDA issued a Cleared decision on June 22, 1995 after a review of 93 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

Submission Details

510(k) Number K951271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1995
Decision Date June 22, 1995
Days to Decision 93 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 127d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 208
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K951271.
ARGEDENT BIO 87 PF
K954368 · Argen Precious Metals, Inc. · Oct 1995
SUREFIRE S
K954371 · Argen Precious Metals, Inc. · Oct 1995
AUROLITE 45
K954404 · Argen Precious Metals, Inc. · Oct 1995
AUROLITE 80
K952403 · Argen Precious Metals, Inc. · Jun 1995
AURIUM 68M
K952402 · Argen Precious Metals, Inc. · Jun 1995
AUROLITE 55
K950858 · Argen Precious Metals, Inc. · Mar 1995