Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
Predetermined Change
Control Plan Authorized		 No
-
-