
Ivoclar North America, Inc.
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EOS BLUEPHASE-P AND REDPHASE-P IMPRESSION MATERIAL is an FDA 510(k)-cleared medical device (K896468) manufactured by Ivoclar North America, 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 April 29, 1990. Regulation: 8.