510(k) K160398

MRI Compatibility for Existing Zimmer Dental Implant Systems by Zimmer Dental, Inc. — Product Code DZE

K160398 is an FDA 510(k) premarket notification submitted by Zimmer Dental, Inc. for the device "MRI Compatibility for Existing Zimmer Dental Implant Systems". The FDA issued a decision of Substantially Equivalent on May 17, 2017. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Zimmer Dental, Inc. has at least 10 other 510(k) clearances on record.