ORTHODONTIC PLASTIC BRACKET— 510(k) K891372

Name: FDA 510(k) clearance K891372
Creator: U.S. Food and Drug Administration
Published: 1989-03-31

Substantially Equivalent

American Orthodontics

FDA 510(k) clearance K891372 for ORTHODONTIC PLASTIC BRACKET, Substantially Equivalent on 1989-03-31. Applicant: American Orthodontics. Device class: 2.

Clearance details

Applicant: American Orthodontics
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 1989-03-09
Decision date: 1989-03-31
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.