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 cleanser, root canal
510(k) Number K103244
Device Name QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION
Applicant
DENTSPLY INTL., INC.
SUSQUEHANNA COMMERCE CENTER
221 W PHILADELPHIA ST. STE 60
YORK,  PA  17404
Applicant Contact HELEN LEWIS
Correspondent
DENTSPLY INTL., INC.
SUSQUEHANNA COMMERCE CENTER
221 W PHILADELPHIA ST. STE 60
YORK,  PA  17404
Correspondent Contact HELEN LEWIS
Classification Product Code
KJJ  
Date Received11/02/2010
Decision Date 02/14/2011
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-