• 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 handpiece, air-powered, root canal irrigation
510(k) Number K162436
Device Name EndoVac Pure
Kerr Corporation
1717 W. Collins Ave
Orange,  CA  92867
Applicant Contact Mohammad Saad Ansari
Sybron Dental Specialties
1717 W. Collins Ave
Orange,  CA  92867
Correspondent Contact Mohammad Saad Ansari
Regulation Number872.4200
Classification Product Code
Date Received08/31/2016
Decision Date 12/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No