
Lancer Orthodontics, Inc.
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O.A.S.I. SYSTEM is an FDA 510(k)-cleared medical device (K051552) manufactured by Lancer Orthodontics, 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 September 18, 2005. Regulation: 8.