510(k) K183242

ET IV SA Dental Implants by Hiossen, Inc. — Product Code DZE

K183242 is an FDA 510(k) premarket notification submitted by Hiossen, Inc. for the device "ET IV SA Dental Implants". The FDA issued a decision of Substantially Equivalent on May 21, 2019. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Hiossen, Inc. has at least 10 other 510(k) clearances on record.