• 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 K190871
Device Name Bio-TackS Orthodontic Mini Implant
Applicant
Bio Cetec Co., Ltd.
RM 1001-1002 New T Castle, 108, Gasan digital 2-ro
Geumcheon-gu
Seoul,  KR 08506
Applicant Contact Hee Sue Jin
Correspondent
MTech Group Inc.
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number872.3640
Classification Product Code
OAT  
Date Received04/03/2019
Decision Date 01/17/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-