• 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 implant, endosseous, orthodontic
510(k) Number K202790
Device Name Syntec Orthodontic Mini Screw Extended System
Syntec Scientific Corporation
No.2, Kung San Road Chuan Shing Industrial Zone, Shen Kang
Chang Hua,  TW 50971
Applicant Contact Nicole Tseng
Syntec Scientific Corporation - Taipei Office
3F., No.96, Sec. 3, Zhongxio East Road Da'An Dist.,
Taipei,  TW 10652
Correspondent Contact Nicole Tseng
Regulation Number872.3640
Classification Product Code
Date Received09/22/2020
Decision Date 09/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No