Dear Healthcare Professional Letters
Voluntary removal of crown indication for 3M™ ESPE™ Lava™ Ultimate CAD/CAM Restorative and 3M™ ESPE™ Lava™ Ultimate Implant Crown Restorative
Audiences
Healthcare professional
Product type
Medical devices
24 July 2015
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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.
Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in 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://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 ‘Useful links’.
Step 3: Click on ‘MOH Alert’ and log in via Singpass.
Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.