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 K140293
Device Name TOUAREG NP CLOSEFIT DENTAL IMPLANTS SYSTEM
Applicant
Adin Dental Implants Systems , Ltd.
Alon Tavor Industrial Zone
Pob 1128 Afula Elit,  IL 1811101
Applicant Contact NISSIM SHAKED
Correspondent
Adin Dental Implants Systems , Ltd.
Alon Tavor Industrial Zone
Pob 1128 Afula Elit,  IL 1811101
Correspondent Contact NISSIM SHAKED
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received02/05/2014
Decision Date 10/31/2014
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
-
-