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 K161655
Device Name On1 Concept
Applicant
NOBEL BIOCARE AB
BOX 5190, SE-402 26, VASTRA HAMNGATAN 1
GOTEBORG,  SE SE-411 17
Applicant Contact CHARLEMAGNE CHUA
Correspondent
NOBEL BIOCARE USA LLC
22715 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Correspondent Contact CHARLEMAGNE CHUA
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/16/2016
Decision Date 02/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-