510(k) K241753

Immediate Molar Implants by Biomet 3i, LLC — Product Code DZE

K241753 is an FDA 510(k) premarket notification submitted by Biomet 3i, LLC for the device "Immediate Molar Implants". The FDA issued a decision of Substantially Equivalent on October 23, 2024. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Biomet 3i, LLC has at least 10 other 510(k) clearances on record.