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Ivoclar Vivadent, Inc.
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ASTRALIS 10, MODELS # 559588, 561859 is an FDA 510(k)-cleared medical device (K013275) manufactured by Ivoclar Vivadent, Inc.. 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 18, 2001. Regulation: 8.