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 K191152
Device Name MIS Ti-base Abutment
Applicant
Dentsply Sirona
221 West Philadelphia Street, Suite 60W
York,  PA  17401
Applicant Contact Karl Nittinger
Correspondent
Dentsply Sirona
221 West Philadelphia Street, Suite 60W
York,  PA  17401
Correspondent Contact Karl Nittinger
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
PNP  
Date Received05/01/2019
Decision Date 07/06/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-