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 Barrier, Animal Source, Intraoral
510(k) Number K231305
Device Name Endoform Dental Membrane
Applicant
Aroa Biosurgery , Ltd.
2 Kingsford Smith Place
Airport Oaks
Auckland,  NZ 2022
Applicant Contact Tina O'Brien
Correspondent
Aroa Biosurgery , Ltd.
2 Kingsford Smith Place
Airport Oaks
Auckland,  NZ 2022
Correspondent Contact Isabela Monteiro
Regulation Number872.3930
Classification Product Code
NPL  
Subsequent Product Code
NPM  
Date Received05/05/2023
Decision Date 01/23/2024
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
-
-