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 K191191
Device Name Neodent Implant System - Temporary Abutments
Applicant
JJGC Industria e Comercio de Materiais Dentarios S.A.
Av. Juscelino Kubitschek de Oliveira, 3291 - CIC
Curitiba,  BR 81270-200
Applicant Contact Mariana Soares Hartmann
Correspondent
Straumann USA, LLC
60 Minuteman Road
Andover,  MA  01810
Correspondent Contact Jennifer M. Jackson
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/03/2019
Decision Date 12/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-