ARDENT FUTURA NON GAMMA-2— 510(k) K964775

Name: FDA 510(k) clearance K964775
Creator: U.S. Food and Drug Administration
Published: 1996-12-10

Substantially Equivalent

Ardent Production Development

FDA 510(k) clearance K964775 for ARDENT FUTURA NON GAMMA-2, Substantially Equivalent on 1996-12-10. Applicant: Ardent Production Development. Device class: 2.

Clearance details

Applicant: Ardent Production Development
Product code: Code EJJ
Device class: Class 2
Regulation: 21 CFR 872.3070
Advisory panel: Dental
Date received: 1996-10-17
Decision date: 1996-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tonawanda, NY, US

Download summary PDF View on FDA.gov ↗

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