
Tp Orthodontics, Inc.
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TP Orthodontics Clear Aligner System is an FDA 510(k)-cleared medical device (K193385) manufactured by Tp Orthodontics, 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 November 11, 2020. Regulation: 8.