3M issues change in indication for restorative product
June 19, 2015
St. Paul, Minn
. – 3M ESPE Dental announced
this week its Lava Ultimate CAD/CAM restorative product should not be used for crowns and is offering refunds for returned unused blocks/frames.
The company is removing the crown indication for the product because the crowns are debonding at a higher-than-anticipated rate and "therefore not consistently meeting 3M's high standards for quality and performance," the company said in a notice on its website this week.
The product continues to be indicated for inlays, onlays (with an internal retentive design element) and veneer restoratives, according to 3M.
The company sent letters this week to purchasers of the product, including dental offices and laboratories.
The letter offers a refund for each returned unused blocks/frames, but the company advised that there is no need to contact patients with existing Lava Ultimate restorations or to take additional action "beyond normal patient care."
The company also has posted
updated instructions for use on its website and asks that anyone with questions contact its customer care center at 1-800-634-2249. ADA members with questions can also contact the Association's Member Service Center via the toll-free number or email firstname.lastname@example.org
ADA News will update this story as information becomes available.