GENERATION 8 SE ADHESIVE— 510(k) K072480

Name: FDA 510(k) clearance K072480
Creator: U.S. Food and Drug Administration
Published: 2007-11-21

Substantially Equivalent

Pentron Clinical Technologies

FDA 510(k) clearance K072480 for GENERATION 8 SE ADHESIVE, Substantially Equivalent on 2007-11-21. Applicant: Pentron Clinical Technologies. Device class: 2.

Clearance details

Applicant: Pentron Clinical Technologies
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2007-09-04
Decision date: 2007-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

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