NICKLE-TITANIUM ORTHODONTIC WIRE— 510(k) K891327

Name: FDA 510(k) clearance K891327
Creator: U.S. Food and Drug Administration
Published: 1989-05-10

Substantially Equivalent

American Orthodontics

FDA 510(k) clearance K891327 for NICKLE-TITANIUM ORTHODONTIC WIRE, Substantially Equivalent on 1989-05-10. Applicant: American Orthodontics. Device class: 2.

Clearance details

Applicant: American Orthodontics
Product code: Code FJF
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1989-03-10
Decision date: 1989-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheboygan, WI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.