510(k) K053014

POLY SILOXANE IMPRESSION MATERIAL by Clinician'S Choice Dental Products, Inc. — Product Code ELW

K053014 is an FDA 510(k) premarket notification submitted by Clinician'S Choice Dental Products, Inc. for the device "POLY SILOXANE IMPRESSION MATERIAL". The FDA issued a decision of Substantially Equivalent on November 15, 2005. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Clinician'S Choice Dental Products, Inc. has at least 1 other 510(k) clearance on record.