
Dentsply Intl.
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ARTIFICIAL TEETH, PORCELAIN, MODIFIED is an FDA 510(k)-cleared medical device (K860608) manufactured by Dentsply Intl.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 25, 1986. Regulation: 8.