510(k) K160097

Image Fast Set, Image Regular Set by Sybron Dental Specialties — Product Code ELW

K160097 is an FDA 510(k) premarket notification submitted by Sybron Dental Specialties for the device "Image Fast Set, Image Regular Set". The FDA issued a decision of Substantially Equivalent on August 5, 2016. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Sybron Dental Specialties has at least 10 other 510(k) clearances on record.