
Fisma, Inc.
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DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50 is an FDA 510(k)-cleared medical device (K991464) manufactured by Fisma, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 19, 1999. Regulation: 8.