Cleared Traditional

K931089 - VGA-50 GOLD ALLOY

K931089 is the FDA 510(k) clearance for VGA-50 GOLD ALLOY by Vident. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K931089 · Vident · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
83d
Days
Class 2
Risk

K931089 is an FDA 510(k) clearance for the VGA-50 GOLD ALLOY. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Vident (Baldwin Park, US). The FDA issued a Cleared decision on May 25, 1993 after a review of 83 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 Vident devices

Submission Details

510(k) Number K931089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1993
Decision Date May 25, 1993
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
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 K931089.
ARGELITE 55
K931475 · Argen Precious Metals, Inc. · Jul 1993
FREEDOM PLUS (CODE NAME MISC-LIB-013)
K932130 · J.F. Jelenko & Co., Inc. · Jul 1993
DW207 #28G, DW207 #35F, DW207 #39LC
K931365 · Ivoclar North America, Inc. · Jun 1993
PALLADIUS-6 ALLOY SEMI-PRECIOUS ALLOY
K931090 · Vident · May 1993
VS1 GPF, VACU PF
K925973 · Metalor Dental USA Corp. · Mar 1993
CASTING GOLD,CERAMIC,GOLD WIRE,ALLOY PRECISION ATT
K925974 · Metalor Dental USA Corp. · Mar 1993