
The Dental Medical Device Co., LLC
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POSI-STOP/POSI-TRAC SYSTEM is an FDA 510(k)-cleared medical device (K981997) manufactured by The Dental Medical Device Co., LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 11, 1999. Regulation: 8.