Advanced Intermezzo Implant System
K-Number: K191127 · 2019-10-08
ApplicantMegagen Implant Co., Ltd.
Decision Date2019-10-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Advanced Intermezzo Implant System is a medical device manufactured by Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2019-10-08 under approval number K191127. 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 Advanced Intermezzo Implant System?
Advanced Intermezzo Implant System is a medical device that received FDA 510(k) clearance on 2019-10-08. It is manufactured by Megagen Implant Co., Ltd.. The 510(k) number is K191127.
When was Advanced Intermezzo Implant System approved by the FDA?
Advanced Intermezzo Implant System received FDA 510(k) clearance on 2019-10-08, under approval number K191127.
What company makes Advanced Intermezzo Implant System?
Advanced Intermezzo Implant System is manufactured by Megagen Implant Co., Ltd..
What is the FDA product code for Advanced Intermezzo Implant System?
The FDA product code for Advanced Intermezzo Implant System is DZE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.