RADIANCE— 510(k) K080749

Substantially Equivalent

American Orthodontics

FDA 510(k) clearance K080749 for RADIANCE, Substantially Equivalent on 2008-08-04. Applicant: American Orthodontics. Device class: 2.

Clearance details

Applicant
American Orthodontics
Product code
Code NJM
Device class
Class 2
Regulation
21 CFR 872.5470
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sheboygan, WI, US
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