Cleared Traditional

K002122 - VECTOR
(FDA 510(k) Clearance)

K002122 · Air Techniques, Inc. · Dental device

Dec 2000

Decision

161d

Days

Class 2

Risk

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

Submitted by Air Techniques, Inc. (Hicksville, US). The FDA issued a Cleared decision on December 21, 2000, 161 days after receiving the submission on July 13, 2000.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.

Submission Details

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