
Ivoclar Vivadent, AG
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FLUOR PROTECTOR S is an FDA 510(k)-cleared medical device (K131487) manufactured by Ivoclar Vivadent, AG. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 7, 2014. Regulation: 8.