• 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 K191774
Device Name SmileAlign Orthodontic Aligner System
Applicant
3D Global Biotech Inc.
21F.-1, No.99, Sec. 1, Xintai 5th Rd., Xizhi Dist.,
New Taipei City 221,  TW
Applicant Contact Keng-Liang Ou
Correspondent
DuoCare, LLC
370 W Grand Blvd #110,
Corona,  CA  92882
Correspondent Contact Diana Lam
Regulation Number872.5470
Classification Product Code
NXC  
Date Received07/02/2019
Decision Date 09/30/2019
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
-
-