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 K053091
Device Name PROCERA IMPLANT BRIDGE ZIRCONIA
Applicant
NOBEL BIOCARE AB
22715 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Applicant Contact PHUONG NGUYEN SON
Correspondent
NOBEL BIOCARE AB
22715 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Correspondent Contact PHUONG NGUYEN SON
Regulation Number872.3630
Classification Product Code
NHA  
Date Received11/03/2005
Decision Date 01/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-