Kavo Corund Handpiece 2013

FDA 510(k) K002708 · Kavo America

Substantially Equivalent

510(k) numberK002708

Submission

Device name
Kavo Corund Handpiece 2013
Applicant
Kavo America
Lake Zurich, IL, US
Received
August 30, 2000
Decision date
November 28, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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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K051909DiagnodentNBL · Traditional 10/21/2005SE
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K050744Kavo Ergocom/ErgocamLLZ · Traditional 04/21/2005SE
K050019In Exam Intraoral Dental X-Ray SystemEHD · Traditional 01/31/2005SE
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Questions and answers

When was Kavo Corund Handpiece 2013 cleared by the FDA?

Kavo Corund Handpiece 2013 (K002708) received a 510(k) decision of Substantially Equivalent on November 28, 2000, 90 days after the submission was received.

What is the product code of K002708?

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