NUBRACE INVISIBLE REMOVABLE ORTHODONTICS


Device Classification Name

aligner, sequential

510(k) Number K073121
Device Name NUBRACE INVISIBLE REMOVABLE ORTHODONTICS
Applicant
NUBRACE, INC.
555 thirteenth st. nw
columbia square
washington, 
DC 
20004

Applicant Contact jonathan s kahan
Correspondent
NUBRACE, INC.
555 thirteenth st. nw
columbia square
washington, 
DC 
20004

Correspodent Contact jonathan s kahan
Regulation Number 872.5470
Classification Product Code
NXC  
Date Received 11/05/2007
Decision Date 02/12/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No