SPI ELEMENT PLATFORM O 4.0 MM

SPI ELEMENT PLATFORM O 4.0 MM is an FDA 510(k)-cleared medical device (K070007) manufactured by Thommen Medical AG. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 9, 2007. Regulation: 8.