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 K190718
FOIA Releasable 510(k) K190718
Device Name Zygomatic Implants
Applicant
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Av. Juscelino Kubitschek De Oliveira, 3291- Cic
Curitiba,  BR 8127 0-200
Applicant Contact Mariana Soares Hartmann
Correspondent
Straumann USA, LLC
60 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Jennifer M. Jackson
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received03/20/2019
Decision Date 07/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-