510(k) K131068

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

K131068 is an FDA 510(k) premarket notification submitted by Kuraray Noritake Dental, Inc. for the device "TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID". The FDA issued a decision of Substantially Equivalent on August 27, 2013. 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.