Cleared Traditional

K002122 - VECTOR

K002122 is an FDA 510(k) clearance for VECTOR, manufactured by Air Techniques, Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K002122 · Air Techniques, Inc. · Dental device
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Dec 2000
Decision
161d
Days
Class 2
Risk

K002122 is an FDA 510(k) clearance for the VECTOR. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on December 21, 2000 after a review of 161 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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 - K002122

510(k) Number K002122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2000
Decision Date December 21, 2000
Days to Decision 161 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
33d slower than avg
Panel avg: 128d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELC Scaler, Ultrasonic

All 191
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K002122.
MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT
K012060 · Hu-Friedy Mfg. Co., Inc. · Jul 2001
DELDENT ULTRASONIC INSERTS
K011179 · Deldent , Ltd. · Jun 2001
PREMIER ULTRASONIC SCALER AND INSERTS
K010195 · Premier Dental Products Co. · Apr 2001
TKD SCALERS
K000846 · Orasystems · Dec 2000
SPARTAN A-10
K002753 · Spartan Ultrasonics, Inc. · Dec 2000
SPARTAN MTS
K002521 · Spartan Marketing Group · Nov 2000
K002122 · VECTOR
Download PDF Air Techniques, Inc.