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Rhein 83 Srl
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MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK is an FDA 510(k)-cleared medical device (K033630) manufactured by Rhein 83 Srl. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 20, 2004. Regulation: 8.