510(k) K242661

TRI-matrix® X-Force Implants by Tri Dental Implants Int. AG — Product Code DZE

K242661 is an FDA 510(k) premarket notification submitted by Tri Dental Implants Int. AG for the device "TRI-matrix® X-Force Implants". The FDA issued a decision of Substantially Equivalent on January 8, 2025. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Tri Dental Implants Int. AG has at least 2 other 510(k) clearances on record.