510(k) K251280

DESS® Dental Implants by Terrats Medical SL — Product Code DZE

K251280 is an FDA 510(k) premarket notification submitted by Terrats Medical SL for the device "DESS® Dental Implants". The FDA issued a decision of Substantially Equivalent on July 23, 2025. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Terrats Medical SL has at least 10 other 510(k) clearances on record.