• 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 cement, dental
510(k) Number K191548
Device Name Nexus Universal Self-Cure
Kerr Corporation
1717 W. Collins Ave
Orange,  CA  92867
Applicant Contact Ardrena Jackson
Sybron Dental Specialties
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact Ardrena Jackson
Regulation Number872.3275
Classification Product Code
Date Received06/12/2019
Decision Date 10/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls