• 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 agent, tooth bonding, resin
510(k) Number K191523
Device Name Visalys Restorative Primer
Applicant
Kettenbach GmbH & Co. KG
Im Heerfeld 7
eschenburg,  DE 35713
Applicant Contact katja simon
Correspondent
Kettenbach GmbH & Co. KG
Im Heerfeld 7
eschenburg,  DE 35713
Correspondent Contact katja simon
Regulation Number872.3200
Classification Product Code
KLE  
Date Received06/10/2019
Decision Date 10/09/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-