RELI-ON ONE STEP, ORTHODONTIC ADHESIVE— 510(k) K053379

Name: FDA 510(k) clearance K053379
Creator: U.S. Food and Drug Administration
Published: 2006-01-25

Substantially Equivalent

Classone Orthodontics, Inc.

FDA 510(k) clearance K053379 for RELI-ON ONE STEP, ORTHODONTIC ADHESIVE, Substantially Equivalent on 2006-01-25. 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: 2005-12-05
Decision date: 2006-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lubbock, TX, US

Download summary PDF View on FDA.gov ↗

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