• 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 K231072
Device Name Anthogyr FlexiBase® titanium bases for Axiom® BL
Applicant
Anthogyr
2237 Avenue André Lasquin
Sallanches,  FR 74700
Applicant Contact Estelle Salle
Correspondent
Straumann USA, LLC
60 Minuteman Road
Andover,  MA  01801
Correspondent Contact Jennifer M. Jackson, MS
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
PNP  
Date Received04/14/2023
Decision Date 01/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-