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 Bracket, Ceramic, Orthodontic
510(k) Number K172845
Device Name Symetri Clear
Applicant
Ormco Corporation
1717 W. Collins Avenue
Orange,  CA  92867
Applicant Contact Tara Bonny
Correspondent
Ormco Corporation
1717 W. Collins Avenue
Orange,  CA  92867
Correspondent Contact Tara Bonny
Regulation Number872.5470
Classification Product Code
NJM  
Date Received09/19/2017
Decision Date 01/31/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-