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 implant, endosseous, root-form
510(k) Number K223697
Device Name MRI compatibility for existing BioHorizons dental implants and abutments
Applicant
BioHorizons Implant Systems, Inc.
2300 Riverchase Center
Birmingham,  AL  35244
Applicant Contact Paul Leppo
Correspondent
BioHorizons Implant Systems, Inc.
2300 Riverchase Center
Birmingham,  AL  35244
Correspondent Contact Jared Cooper
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received12/09/2022
Decision Date 10/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-