Cleared Traditional

K942698 - VACSTAR

K942698 is the FDA 510(k) clearance for VACSTAR by Air Techniques, Inc.. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K942698 · Air Techniques, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
282d
Days
Class 1
Risk

K942698 is an FDA 510(k) clearance for the VACSTAR. 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 17, 1995 after a review of 282 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 K942698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1994
Decision Date March 17, 1995
Days to Decision 282 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
155d slower than avg
Panel avg: 127d · This submission: 282d
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 K942698.
DENTAL TRAY, STERILE, DISPOSABLE
K974238 · Trinity Laboratories, Inc. · Feb 1998
A-DEC SELF-CONTAINED WATER SYSTEM
K962665 · A-Dec, Inc. · Aug 1996
A-DEC PERFORMER CONTROL UNIT
K960506 · A-Dec, Inc. · Mar 1996
A-DEC RADIUS 2122/2132
K940893 · A-Dec, Inc. · Jul 1994
A-DEC CASCADE 3072 WALLMOUNT
K935325 · A-Dec, Inc. · Apr 1994
A-DEC 2544 DOCTORS IC MICRO-CART
K925797 · A-Dec, Inc. · Jan 1994