
Dentsply Intl.
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ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285 is an FDA 510(k)-cleared medical device (K994211) manufactured by Dentsply Intl.. 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 February 3, 2000. Regulation: 8.