The Fugo Blade for Dentistry

FDA 510(k) K063468 · Medisurg , Ltd.

Substantially Equivalent

510(k) numberK063468

Submission

Device name
The Fugo Blade for Dentistry
Applicant
Medisurg , Ltd.
Norristown, PA, US
Received
November 16, 2006
Decision date
April 18, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EKZ – Unit, Electrosurgical, And Accessories, Dental
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4920
Specialty
Dental

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Questions and answers

When was The Fugo Blade for Dentistry cleared by the FDA?

The Fugo Blade for Dentistry (K063468) received a 510(k) decision of Substantially Equivalent on April 18, 2007, 153 days after the submission was received.

What is the product code of K063468?

The FDA product code is EKZ – Unit, Electrosurgical, And Accessories, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.4920.