FDA · official record K221488Substantially Equivalent

Z7 Zirconia Implant System

Name: Z7 Zirconia Implant System — FDA K221488
Creator: Z7, LLC
Keywords: Z7 Zirconia Implant System, Z7 Zirconia Implant System, K221488, DZE, FDA

United StatesDZEZ7, LLC

Verified

Official record identity

FDA application number: K221488
Decision date: June 26, 2023
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Z7, LLC

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2022-05-23
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3640

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.