
Ultradent Products, Inc.
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OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 is an FDA 510(k)-cleared medical device (K071055) manufactured by Ultradent Products, 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 2, 2007. Regulation: 8.