Cleared Traditional

K972683 - V-DELTA 450

K972683 is an FDA 510(k) clearance for V-DELTA 450, 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 32-day FDA review.

K972683 · Metalor Dental USA Corp. · Dental device
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Optimized for regulatory review, auditing and printing
Aug 1997
Decision
32d
Days
Class 2
Risk

K972683 is an FDA 510(k) clearance for the V-DELTA 450. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Metalor Dental USA Corp. (North Attleborough, US). The FDA issued a Cleared decision on August 18, 1997 after a review of 32 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

FDA 510(k) Submission Details - K972683

510(k) Number K972683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1997
Decision Date August 18, 1997
Days to Decision 32 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
95d faster than avg
Panel avg: 127d · This submission: 32d
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 K972683.
STABILOR HN
K973288 · Degussa Corp. · Nov 1997
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ALFALLOY
K972534 · Aalba Dent, Inc. · Sep 1997
AUROFLUID 22
K970044 · Metalor Dental USA Corp. · Mar 1997
SOLARO 33
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K964705 · Gateway Alloys, Inc. · Dec 1996