• 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
3Shape A/S
Holmens Kanal 7
Copenhagen,  DK 1060
Applicant Contact Hanne Nielsen
3Shape A/S
Holmens Kanal 7
Copenhagen,  DK 1060
Correspondent Contact Hanne Nielsen
Regulation Number872.5470
Classification Product Code
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