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 K233083
Device Name Osteon Precision Milled Suprastructure
Applicant
Implant Solutions Pty Ltd (Aka Osteon Medical)
759-767 Springvale Rd.
Mulgrave,  AU 3170
Applicant Contact Farah Rahman
Correspondent
Implant Solutions Pty Ltd (Aka Osteon Medical)
759-767 Springvale Rd.
Mulgrave
Victoria,  AU 3170
Correspondent Contact Farah Rahman
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/26/2023
Decision Date 03/09/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-