
Dentsply Intl.
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ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401 is an FDA 510(k)-cleared medical device (K000112) manufactured by Dentsply Intl.. This device is classified under the Dental specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 12, 2000. Regulation: 8.