510(k) K233859

BASIS FLOW II by YAMAHACHI DENTAL MFG., Co. — Product Code EBI

K233859 is an FDA 510(k) premarket notification submitted by YAMAHACHI DENTAL MFG., Co. for the device "BASIS FLOW II". The FDA issued a decision of Substantially Equivalent on March 5, 2024. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. YAMAHACHI DENTAL MFG., Co. has at least 2 other 510(k) clearances on record.