• 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 K212676
Device Name Osteon Precision Milled Suprastructure
Applicant
Implant Solutions PTY LTD (Osteon Medical)
759-767 Springvale Road
Mulgrave,  AU 3170
Applicant Contact Andrea Del Ciotto
Correspondent
PaxMed International, LLC
12264 EL Camino Real, Suite 400
San Diego,  CA  92130
Correspondent Contact Melissa Burbage
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/24/2021
Decision Date 03/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-