PLANMECA PROMAX 3D— 510(k) K060328

Substantially Equivalent

Planmeca Oy

FDA 510(k) clearance K060328 for PLANMECA PROMAX 3D, Substantially Equivalent on 2006-03-15. 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: 2006-02-09
Decision date: 2006-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

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