NOBELPHARMA CEASING 3.0 mm BRANEMARK ENDOSSEOUS IMPLANT U.S. SHIPMENTS
This article was originally published in The Gray Sheet
Executive Summary
NOBELPHARMA CEASING 3.0 mm BRANEMARK ENDOSSEOUS IMPLANT U.S. SHIPMENTS following receipt of a March 7 FDA warning letter. Although voluntarily halting U.S. distribution indefinitely, the firm is considering enlarging the devices to at least 3.25 mm in order to fit FDA's definition of an endosseous implant substantially equivalent to one legally marketed prior to the 1976 Medical Device Amendments. The warning letter advises the Swedish manufacturer of endosseous implants and dental instruments that until the firm demonstrates substantial equivalence, the 3.0 mm device will be denied entry into the U.S.