510(k) K200676

ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA by Zirkonzahn Srl — Product Code EBG

K200676 is an FDA 510(k) premarket notification submitted by Zirkonzahn Srl for the device "ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA". The FDA issued a decision of Substantially Equivalent on July 8, 2020. The device falls under product code EBG (Crown And Bridge, Temporary, Resin), a Class II device regulated under 21 CFR 872.3770. Zirkonzahn Srl has at least 10 other 510(k) clearances on record.