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American Eagle Instruments, Inc.
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AEI DR. TERAUCHI ULTRASONIC TIPS is an FDA 510(k)-cleared medical device (K122501) manufactured by American Eagle Instruments, 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 March 28, 2013. Regulation: 8.