
Dentsply Intl., Inc.
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PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II is an FDA 510(k)-cleared medical device (K093221) manufactured by Dentsply Intl., 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 October 29, 2009. Regulation: 8.