DIMEX 2— 510(k) K000454

Substantially Equivalent

Planmeca Oy

FDA 510(k) clearance K000454 for DIMEX 2, Substantially Equivalent on 2000-03-31. Applicant: Planmeca Oy. Device class: 2.

Clearance details

Applicant: Planmeca Oy
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2000-02-11
Decision date: 2000-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wood Dale, IL, 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.