Cleared Traditional

K925973 - VS1 GPF

K925973 is the FDA 510(k) clearance for VS1 GPF by Metalor Dental USA Corp.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K925973 · Metalor Dental USA Corp. · Dental device
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Mar 1993
Decision
126d
Days
Class 2
Risk

K925973 is an FDA 510(k) clearance for the VS1 GPF, VACU PF. 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 March 31, 1993 after a review of 126 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 K925973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1992
Decision Date March 31, 1993
Days to Decision 126 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
1d faster than avg
Panel avg: 127d · This submission: 126d
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 435
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K925973.
DW207 #28G, DW207 #35F, DW207 #39LC
K931365 · Ivoclar North America, Inc. · Jun 1993
VGA-50 GOLD ALLOY
K931089 · Vident · May 1993
PALLADIUS-6 ALLOY SEMI-PRECIOUS ALLOY
K931090 · Vident · May 1993
CASTING GOLD,CERAMIC,GOLD WIRE,ALLOY PRECISION ATT
K925974 · Metalor Dental USA Corp. · Mar 1993
DENTAL CASTING ALLOY MODIFICATION-PF-4
K930481 · Deringer-Ney, Inc. · Mar 1993
DENTAL CASTING ALLOY, MODIFICATION - PF-3
K930482 · Deringer-Ney, Inc. · Mar 1993