BIO 60— 510(k) K041378

Substantially Equivalent

Kodent, Inc.

FDA 510(k) clearance K041378 for BIO 60, Substantially Equivalent on 2004-08-02. Applicant: Kodent, Inc.. Device class: 2.

Clearance details

Applicant: Kodent, Inc.
Product code: Code EJT
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 2004-05-24
Decision date: 2004-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.