Bonart ART-E1 Electrosurgery Unit

FDA 510(k) K020080 · Diagnostic Data, Inc.

Substantially Equivalent

510(k) numberK020080

Submission

Device name
Bonart ART-E1 Electrosurgery Unit
Applicant
Diagnostic Data, Inc.
Upland, CA, US
Received
January 9, 2002
Decision date
February 19, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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K063468The Fugo Blade for DentistryEKZ · Traditional Medisurg , Ltd.04/18/2007SE
K052622Macan Model MC-4A Dental Electrosurgical UnitEKZ · Traditional Macan Engineering Co.12/09/2005SE
K050735MC6AEKZ · Traditional Macan Engineering Co.05/23/2005SE
K023672X O Odontosurge 4EKZ · Traditional Xo Care A/S04/29/2003SE
K001560Odontosurge 3EKZ · Traditional Odonto-Wave08/24/2000SE
K000768Wallach Quantum 500 Electrosurgical GeneratorEKZ · Traditional Wallach Surgical Devices, Inc.04/11/2000SE
K982229Bi-DentEKZ · Traditional Valley Forge Scientific Corp.08/13/1998SE
K981390Odontosurge 2EKZ · Traditional Periogiene06/11/1998SE

Questions and answers

When was Bonart ART-E1 Electrosurgery Unit cleared by the FDA?

Bonart ART-E1 Electrosurgery Unit (K020080) received a 510(k) decision of Substantially Equivalent on February 19, 2002, 41 days after the submission was received.

What is the product code of K020080?

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