TEMPOFIT, MODEL 02693

TEMPOFIT, MODEL 02693 is an FDA 510(k)-cleared medical device (K994012) manufactured by Detax GmbH & Co. KG. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 15, 2000. Regulation: 8.