510(k) K251938

GEN5 and GEN5+ Dental Implant System by Paragon Implant Mfg., LLC — Product Code DZE

K251938 is an FDA 510(k) premarket notification submitted by Paragon Implant Mfg., LLC for the device "GEN5 and GEN5+ Dental Implant System". The FDA issued a decision of Substantially Equivalent on October 30, 2025. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Paragon Implant Mfg., LLC has at least 3 other 510(k) clearances on record.