RADIANCE


Device Classification Name

bracket, ceramic, orthodontic

510(k) Number K080749
Device Name RADIANCE
Applicant
AMERICAN ORTHODONTICS
1714 cambridge ave.
sheboygan, 
WI 
53081

Applicant Contact jerome h schomberg
Correspondent
AMERICAN ORTHODONTICS
1714 cambridge ave.
sheboygan, 
WI 
53081

Correspodent Contact jerome h schomberg
Regulation Number 872.5470
Classification Product Code
NJM  
Date Received 03/17/2008
Decision Date 08/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No