510(k) K181484

Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue by Zirkonzahn Srl — Product Code EBF

K181484 is an FDA 510(k) premarket notification submitted by Zirkonzahn Srl for the device "Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue". The FDA issued a decision of Substantially Equivalent on June 18, 2018. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Zirkonzahn Srl has at least 10 other 510(k) clearances on record.