MOLAR DISTALIZING ASSEMBLY— 510(k) K912417

Name: FDA 510(k) clearance K912417
Creator: U.S. Food and Drug Administration
Published: 1991-12-20

Substantially Equivalent

American Orthodontics

FDA 510(k) clearance K912417 for MOLAR DISTALIZING ASSEMBLY, Substantially Equivalent on 1991-12-20. Applicant: American Orthodontics. Device class: 1.

Clearance details

Applicant: American Orthodontics
Product code: Code DYJ
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1991-05-31
Decision date: 1991-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheboygan, WI, US

Download summary PDF View on FDA.gov ↗

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