
Ivoclar North America, Inc.
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VIVAALLOY HR (AMALGAM) is an FDA 510(k)-cleared medical device (K901911) 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 May 31, 1990. Regulation: 8.