CERAMIC BRACKETS


Device Classification Name

bracket, ceramic, orthodontic

510(k) Number K110335
Device Name CERAMIC BRACKETS
Applicant
ORTHO ORGANIZERS, INC.
1822 aston avenue
carlsbad, 
CA 
92008 -7603

Applicant Contact foster boop
Correspondent
ORTHO ORGANIZERS, INC.
1822 aston avenue
carlsbad, 
CA 
92008 -7603

Correspodent Contact foster boop
Regulation Number 872.5470
Classification Product Code
NJM  
Date Received 02/04/2011
Decision Date 05/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No