510(k) K151332

Nexus Universal, Nexus Universal Chroma by Sybron Dental Specialties — Product Code EMA

K151332 is an FDA 510(k) premarket notification submitted by Sybron Dental Specialties for the device "Nexus Universal, Nexus Universal Chroma". The FDA issued a decision of Substantially Equivalent on August 17, 2015. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Sybron Dental Specialties has at least 10 other 510(k) clearances on record.