Cleared Traditional

V-DELTA 450

K972683 · Metalor Dental USA Corp. · Dental
Aug 1997
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K972683 is an FDA 510(k) clearance for the V-DELTA 450, a Alloy, Other Noble Metal (Class II — Special Controls, product code EJS), submitted by Metalor Dental USA Corp. (North Attleborough, US). The FDA issued a Cleared decision on August 18, 1997, 32 days after receiving the submission on July 17, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K972683 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EJS — Alloy, Other Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060