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 Implant, Endosseous, Orthodontic
510(k) Number K210559
Device Name ATOZ Mini-Screw
Applicant
MK Meditech Inc.
Room# 511, 54, Changeop-ro, Sujeong-gu,
Seongnam-si,  KR 13449
Applicant Contact SungChul Moon
Correspondent
MK Meditech Inc.
Room# 511, 54, Changeop-ro, Sujeong-gu,
Seongnam-si,  KR 13449
Correspondent Contact SungChul Moon
Regulation Number872.3640
Classification Product Code
OAT  
Date Received02/25/2021
Decision Date 12/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-