
Fibra Sonics, Inc.
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HYGIENTIST; CYCLOSON I & II; RETROFIT is an FDA 510(k)-cleared medical device (K812909) manufactured by Fibra Sonics, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 13, 1981. Regulation: 8.