510(k) K251775

RODIN Cement by Belport Company, Inc., Gingi-Pak — Product Code EMA

K251775 is an FDA 510(k) premarket notification submitted by Belport Company, Inc., Gingi-Pak for the device "RODIN Cement". The FDA issued a decision of Substantially Equivalent on September 2, 2025. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Belport Company, Inc., Gingi-Pak has at least 10 other 510(k) clearances on record.