Cleared Traditional

VISTACAM OMNI AND VIASTCAM OMNI (IC)

K974204 · Air Techniques, Inc. · Dental
Jan 1998
Decision
59d
Days
Class 1
Risk

About This 510(k) Submission

K974204 is an FDA 510(k) clearance for the VISTACAM OMNI AND VIASTCAM OMNI (IC), a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on January 8, 1998, 59 days after receiving the submission on November 10, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K974204 FDA.gov
FDA Decision Cleared SESE
Date Received November 10, 1997
Decision Date January 08, 1998
Days to Decision 59 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EIA — Unit, Operative Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640

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