
Sybron Dental Specialties
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Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress is an FDA 510(k)-cleared medical device (K153067) manufactured by Sybron Dental Specialties. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 26, 2016. Regulation: 8.