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, Root-Form
510(k) Number K240383
Device Name Highness Implant System
Applicant
highness Co., Ltd.
98-10, Hyeondae-ro, Waegwan-eup, Chilgok-gun
Gyeongsangbuk-do,  KR 39871
Applicant Contact Ji-yun Jeong
Correspondent
E&M
D1474, PyeongCheon Arco Tower, 230, Simin-Daro, Dongan-gu
Anyangsi,  KR 14067
Correspondent Contact Sanghwa Myung
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received02/08/2024
Decision Date 10/31/2024
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
-
-