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 Unit, Operative Dental
510(k) Number K251626
Device Name Midmark Dental Delivery System
Applicant
Midmark Corporation
60 Vista Dr.
Versailles,  OH  45380
Applicant Contact Rachel Schwieterman
Correspondent
Midmark Corporation
60 Vista Dr.
Versailles,  OH  45380
Correspondent Contact Rachel Schwieterman
Regulation Number872.6640
Classification Product Code
EIA  
Date Received05/28/2025
Decision Date 11/03/2025
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
-
-