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 K111390
Device Name SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA..
Applicant
CENDRES & METAUX SA
RUE DE BOUJEAN 122
BIEL/BIENNE,  CH 2501
Applicant Contact TANJA BONGNI
Correspondent
CENDRES & METAUX SA
RUE DE BOUJEAN 122
BIEL/BIENNE,  CH 2501
Correspondent Contact TANJA BONGNI
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/18/2011
Decision Date 09/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-