
Friatec Medical Inc., USA
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FRIALIT(R)-2 STEPPED CYLINDER WITH FRIOS(R) TI-COATING is an FDA 510(k)-cleared medical device (K945849) manufactured by Friatec Medical Inc., USA. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 14, 1996. Regulation: 8.