Cleared Traditional

K020080 - BONART ART-E1 ELECTROSURGERY UNIT
(FDA 510(k) Clearance)

K020080 · Diagnostic Data, Inc. · Dental
Feb 2002
Decision
41d
Days
Class 2
Risk

K020080 is an FDA 510(k) clearance for the BONART ART-E1 ELECTROSURGERY UNIT, a Unit, Electrosurgical, And Accessories, Dental (Class II — Special Controls, product code EKZ), submitted by Diagnostic Data, Inc. (Upland, US). The FDA issued a Cleared decision on February 19, 2002, 41 days after receiving the submission on January 9, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.4920.

Submission Details

510(k) Number K020080 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 2002
Decision Date February 19, 2002
Days to Decision 41 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EKZ — Unit, Electrosurgical, And Accessories, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4920