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Bonart Art-E1 Electrosurgery Unit

by Diagnostic Data, Inc. 510(k)

Active United States

510(k) K020080

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK020080 Date19 Feb 2002ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
EKZ
Device Class
Class II
Regulation
21 CFR Part 872.4920
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent