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 K241692
Device Name MIS LYNX Conical Connection Implant System
Applicant
Dentsply Sirona, Inc.
221 W. Philadelphia St.
Suite 60w
York,  PA  17401
Applicant Contact Laura Sobrin
Correspondent
Dentsply Sirona, Inc.
221 W. Philadelphia St.
Suite 60w
York,  PA  17401
Correspondent Contact Laura Sobrin
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received06/12/2024
Decision Date 11/25/2024
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
-
-