Airdent II CS

FDA 510(k) K001313 · Air Technologies, Inc.

Substantially Equivalent

510(k) numberK001313

Submission

Device name
Airdent II CS
Applicant
Air Technologies, Inc.
Hicksville, NY, US
Received
April 26, 2000
Decision date
June 8, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KOJ – Airbrush
Device class
Class II (moderate risk)
Regulation
21 CFR 872.6080
Specialty
Dental

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Questions and answers

When was Airdent II CS cleared by the FDA?

Airdent II CS (K001313) received a 510(k) decision of Substantially Equivalent on June 8, 2000, 43 days after the submission was received.

What is the product code of K001313?

The FDA product code is KOJ – Airbrush, a Class II (moderate risk) device regulated under 21 CFR 872.6080.