
Ultradent Products, Inc.
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ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 is an FDA 510(k)-cleared medical device (K071106) 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 7, 2007. Regulation: 8.