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 K143630
Device Name Invisalign System
Applicant
Align Technology, Inc.
2560 Orchard Pkwy.
San Jose,  CA  95131
Applicant Contact Margaret Anderson
Correspondent
Align Technology, Inc.
2560 Orchard Pkwy.
San Jose,  CA  95131
Correspondent Contact Margaret Anderson
Regulation Number872.5470
Classification Product Code
NXC  
Date Received12/22/2014
Decision Date 11/18/2015
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
-
-