COMPOSITE ORTHODONTIC BRACKETS— 510(k) K140807

Name: FDA 510(k) clearance K140807
Creator: U.S. Food and Drug Administration
Published: 2014-11-12

Substantially Equivalent

Ortho Specialties

FDA 510(k) clearance K140807 for COMPOSITE ORTHODONTIC BRACKETS, Substantially Equivalent on 2014-11-12. Applicant: Ortho Specialties. Device class: 2.

Clearance details

Applicant: Ortho Specialties
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2014-04-01
Decision date: 2014-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gurnee, IL, US

Download summary PDF View on FDA.gov ↗

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