
Heraeus Kulzer, LLC, Mitsui Chemicals Group
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iBond Universal & iBond Ceramic Primer is an FDA 510(k)-cleared medical device (K150933) manufactured by Heraeus Kulzer, LLC, Mitsui Chemicals Group. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 6, 2015. Regulation: 8.