510(k) K860911

AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL by Austenal Dental, Inc. — Product Code ELW

K860911 is an FDA 510(k) premarket notification submitted by Austenal Dental, Inc. for the device "AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL". The FDA issued a decision of Substantially Equivalent on March 26, 1986. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Austenal Dental, Inc. has at least 10 other 510(k) clearances on record.