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 Abutment, Implant, Dental, Endosseous
510(k) Number K141970
Device Name DIGITEK TITANIUM ABUTMENT
Applicant
Digitek Dental Solutions Limited
93 Kinglam St., Cheung Sha Wan
Units B-C Flat D, 6/F
Kowloon, Hong Kong,  CN 999077
Applicant Contact ALWIN NGAI
Correspondent
Digitek Dental Solutions Limited
93 Kinglam St., Cheung Sha Wan
Units B-C Flat D, 6/F
Kowloon, Hong Kong,  CN 999077
Correspondent Contact ALWIN NGAI
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/21/2014
Decision Date 07/31/2015
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
-
-