TPH Spectra ST Flowable Composite Restorative

TPH Spectra ST Flowable Composite Restorative is an FDA 510(k)-cleared medical device (K182288) manufactured by Dentsply Sirona. 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 19, 2018. Regulation: 8.