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510(k) K020080

BONART ART-E1 ELECTROSURGERY UNIT by Diagnostic Data, Inc. — Product Code EKZ

K020080 is an FDA 510(k) premarket notification submitted by Diagnostic Data, Inc. for the device "BONART ART-E1 ELECTROSURGERY UNIT". The FDA issued a decision of Substantially Equivalent on February 19, 2002. The device falls under product code EKZ (Unit, Electrosurgical, And Accessories, Dental), a Class II device regulated under 21 CFR 872.4920.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2002
Date Received
January 9, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, And Accessories, Dental
Device Class
Class II
Regulation Number
872.4920
Review Panel
DE
Submission Type

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  • K052622 — MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT (December 9, 2005)
  • K050735 — MC6A (May 23, 2005)
  • K023672 — X O ODONTOSURGE 4 (April 29, 2003)
  • K001560 — ODONTOSURGE 3 (August 24, 2000)
  • K000768 — WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (April 11, 2000)
  • K982229 — BI-DENT (August 13, 1998)
  • K981390 — ODONTOSURGE 2 (June 11, 1998)

FDA data resources