510(k) K190662

MRI Compatibility for Existing Straumann Dental Implant Systems by Straumann USA, LLC — Product Code DZE

K190662 is an FDA 510(k) premarket notification submitted by Straumann USA, LLC for the device "MRI Compatibility for Existing Straumann Dental Implant Systems". The FDA issued a decision of Substantially Equivalent on June 17, 2019. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Straumann USA, LLC has at least 10 other 510(k) clearances on record.