LION SE ONE STEP ORTHODONTIC ADHESIVE— 510(k) K080445

Name: FDA 510(k) clearance K080445
Creator: U.S. Food and Drug Administration
Published: 2008-07-16

Substantially Equivalent

Classone Orthodontics, Inc.

FDA 510(k) clearance K080445 for LION SE ONE STEP ORTHODONTIC ADHESIVE, Substantially Equivalent on 2008-07-16. Applicant: Classone Orthodontics, Inc.. Device class: 2.

Clearance details

Applicant: Classone Orthodontics, Inc.
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 2008-02-19
Decision date: 2008-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lubbock, TX, US

Download summary PDF View on FDA.gov ↗

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