
Shinrin-Yoku Traders, LLC
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SilentZPro 2.0 is an FDA 510(k)-cleared medical device (K220688) manufactured by Shinrin-Yoku Traders, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 1, 2022. Regulation: 8.