510(k) K191122

3M RelyX Pediatric Resin Modified Glass Ionomer Cement by 3M Espe Dental Products — Product Code EMA

K191122 is an FDA 510(k) premarket notification submitted by 3M Espe Dental Products for the device "3M RelyX Pediatric Resin Modified Glass Ionomer Cement". The FDA issued a decision of Substantially Equivalent on May 29, 2019. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. 3M Espe Dental Products has at least 10 other 510(k) clearances on record.