510(k) K122421

TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID by Kuraray Noritake Dental, Inc. — Product Code EJK

K122421 is an FDA 510(k) premarket notification submitted by Kuraray Noritake Dental, Inc. for the device "TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID". The FDA issued a decision of Substantially Equivalent on December 11, 2012. The device falls under product code EJK (Liner, Cavity, Calcium Hydroxide), a Class II device regulated under 21 CFR 872.3250. Kuraray Noritake Dental, Inc. has at least 10 other 510(k) clearances on record.