
Dentsply International
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PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM is an FDA 510(k)-cleared medical device (K050386) manufactured by Dentsply International. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 22, 2005. Regulation: 8.