FDA · official record K182620Substantially Equivalent

MRI Compatibility for Existing Neodent Implant System

Name: MRI Compatibility for Existing Neodent Implant System — FDA K182620
Creator: Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Keywords: MRI Compatibility for Existing Neodent Implant System, MRI Compatibility for Existing Neodent Implant System, K182620, DZE, FDA

United StatesDZEJjgc Industria E Comercio DE Materiais Dentarios S.A.

Verified

Official record identity

FDA application number: K182620
Decision date: January 18, 2019
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S.A.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2018-09-24
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.