510(k) K260364

Device 300419 Strip by Geistlich Pharma AG — Product Code MQV

K260364 is an FDA 510(k) premarket notification submitted by Geistlich Pharma AG for the device "Device 300419 Strip". The FDA issued a decision of Substantially Equivalent on June 2, 2026. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Geistlich Pharma AG has at least 10 other 510(k) clearances on record.