Voluntary removal of crown indication for 3M™ ESPE™ Lava™ Ultimate CAD/CAM Restorative and 3M™ ESPE™ Lava™ Ultimate Implant Crown Restorative

3M ESPE Dental would like to inform healthcare professionals of the voluntary removal of crown indication from the list of indications approved for use for 3M™ ESPE™ Lava™ Ultimate CAD/CAM Restorative and 3M™ ESPE™ Lava™ Ultimate Implant Crown Restorative. This is due to reports that Lava™ Ultimate crowns debonded at a rate higher than their typical experience for crowns and significantly exceeded the 2-4% rates generally reported in clinical literature. Health risks associated with crown debonding have been determined to be low in severity and occurrence. Please refer to the letter for details.

 
 
Healthcare professional, Medical devices
Published:

Dear Healthcare Professional Letters

12 Dec 2019

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of the letters can be found on the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://www.hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under 'For Healthcare Professionals’.

Step 2: Click on 'Restricted Content' and log in via SingPass.

Step 3: Click on the MOH Alert icon under ‘Applications’.

Step 4: Click on the Drug Alert tab to view the DHCPLs.