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 Orthodontic Software
510(k) Number K163677
Device Name Ortho System
Applicant
3Shape A/S
Holmens Kanal 7
Copenhagen,  DK 1060
Applicant Contact Hanne Nielsen
Correspondent
3Shape A/S
Holmens Kanal 7
Copenhagen,  DK 1060
Correspondent Contact Hanne Nielsen
Regulation Number872.5470
Classification Product Code
PNN  
Date Received12/27/2016
Decision Date 04/20/2017
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
-
-