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FDA 510(k)

MRI Compatibility for Existing Neodent Implant System

K-Number: K182620 · 2019-01-18

Decision Date2019-01-18
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MRI Compatibility for Existing Neodent Implant System is a medical device manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It received FDA 510(k) clearance on 2019-01-18 under approval number K182620. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRI Compatibility for Existing Neodent Implant System?

MRI Compatibility for Existing Neodent Implant System is a medical device that received FDA 510(k) clearance on 2019-01-18. It is manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K182620.

When was MRI Compatibility for Existing Neodent Implant System approved by the FDA?

MRI Compatibility for Existing Neodent Implant System received FDA 510(k) clearance on 2019-01-18, under approval number K182620.

What company makes MRI Compatibility for Existing Neodent Implant System?

MRI Compatibility for Existing Neodent Implant System is manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A..

What is the FDA product code for MRI Compatibility for Existing Neodent Implant System?

The FDA product code for MRI Compatibility for Existing Neodent Implant System is DZE.

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Official Source

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