
Satelec - Acteon Group
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NEWTRON P5, NEWTRON P5 B.LED is an FDA 510(k)-cleared medical device (K132267) manufactured by Satelec - Acteon Group. 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 9, 2014. Regulation: 8.