ARTISTE SE FLOWABLE COMPOSITE, MODEL N280— 510(k) K072545

Name: FDA 510(k) clearance K072545
Creator: U.S. Food and Drug Administration
Published: 2007-10-26

Substantially Equivalent

Pentron Clinical Technologies

FDA 510(k) clearance K072545 for ARTISTE SE FLOWABLE COMPOSITE, MODEL N280, Substantially Equivalent on 2007-10-26. Applicant: Pentron Clinical Technologies. Device class: 2.

Clearance details

Applicant: Pentron Clinical Technologies
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2007-09-10
Decision date: 2007-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

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