MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES— 510(k) K891775

Name: FDA 510(k) clearance K891775
Creator: U.S. Food and Drug Administration
Published: 1989-05-11

Substantially Equivalent

American Orthodontics

FDA 510(k) clearance K891775 for MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES, Substantially Equivalent on 1989-05-11. Applicant: American Orthodontics. Device class: 1.

Clearance details

Applicant: American Orthodontics
Product code: Code EJF
Device class: Class 1
Regulation: 21 CFR 872.5410
Advisory panel: Dental
Date received: 1989-03-24
Decision date: 1989-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sheboygan, WI, US

Download summary PDF View on FDA.gov ↗

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