
Ivory Super Holdco, Incp.
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LOCATOR R-Tx is an FDA 510(k)-cleared medical device (K200827) manufactured by Ivory Super Holdco, Incp.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 1, 2020. Regulation: 8.