Cleared Traditional

K943204 - VISTACAM

K943204 is an FDA 510(k) clearance for VISTACAM, manufactured by Air Techniques, Inc.. The device is a Class 1 Dental device with 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.

FDA 510(k) Submission Details - K943204

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 128d · This submission: 254d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

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 282
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K943204.
INTRAORAL VIDEO SCOPE AND WINDOW TUBE
K951019 · Cuda Products Co. · May 1995
THE AQUA-AIR PROFESSIONAL FIELD UNIT(S)
K950175 · Aqua-Air Medical Devices, Inc. · Apr 1995
VACSTAR
K942698 · Air Techniques, Inc. · Mar 1995
SPIRIT II AND SPIRIT TREATMENT CENTER
K946187 · Pelton & Crane Co. · Mar 1995
DENTAL OPERATIVE UNIT ACCESORIES
K944271 · Dci Intl. · Dec 1994
OKTAS INTRA-ORAL DENTAL CAMERA
K944256 · Oktas · Nov 1994
K943204 · VISTACAM
Download PDF Air Techniques, Inc.