BIOUNIVERSAL PKF— 510(k) K030435

Substantially Equivalent

Ivoclar Vivadent, Inc.

FDA 510(k) clearance K030435 for BIOUNIVERSAL PKF, Substantially Equivalent on 2003-04-15. Applicant: Ivoclar Vivadent, Inc.. Device class: 2.

Clearance details

Applicant: Ivoclar Vivadent, Inc.
Product code: Code EJT
Device class: Class 2
Regulation: 21 CFR 872.3060
Advisory panel: Dental
Date received: 2003-02-10
Decision date: 2003-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amherst, NY, 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.