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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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
Correspondent Contact JONATHAN S KAHAN
Regulation Number872.5470
Classification Product Code
NXC  
Date Received11/05/2007
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
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