Cleared Traditional

K943204 - VISTACAM

K943204 is the FDA 510(k) clearance for VISTACAM by Air Techniques, Inc.. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K943204 · Air Techniques, Inc. · Dental device
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Mar 1995
Decision
254d
Days
Class 1
Risk

K943204 is an FDA 510(k) clearance for the VISTACAM. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on March 16, 1995 after a review of 254 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Air Techniques, Inc. devices

Submission Details

510(k) Number K943204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1994
Decision Date March 16, 1995
Days to Decision 254 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 127d · This submission: 254d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIA Unit, Operative Dental

All 61
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K943204.
DENTAL TRAY, STERILE, DISPOSABLE
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K935325 · A-Dec, Inc. · Apr 1994
A-DEC 2544 DOCTORS IC MICRO-CART
K925797 · A-Dec, Inc. · Jan 1994