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 Mouthguard, Prescription
510(k) Number K161884
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
Classification Product Code
MQC  
Date Received07/11/2016
Decision Date 04/19/2017
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-