Implant Direct Dental Implant Systems Portfolio - MR Conditional
K-Number: K222211 · 2023-02-02
Decision Date2023-02-02
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Implant Direct Dental Implant Systems Portfolio - MR Conditional is a medical device manufactured by Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2023-02-02 under approval number K222211. 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 Implant Direct Dental Implant Systems Portfolio - MR Conditional?
Implant Direct Dental Implant Systems Portfolio - MR Conditional is a medical device that received FDA 510(k) clearance on 2023-02-02. It is manufactured by Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K222211.
When was Implant Direct Dental Implant Systems Portfolio - MR Conditional approved by the FDA?
Implant Direct Dental Implant Systems Portfolio - MR Conditional received FDA 510(k) clearance on 2023-02-02, under approval number K222211.
What company makes Implant Direct Dental Implant Systems Portfolio - MR Conditional?
Implant Direct Dental Implant Systems Portfolio - MR Conditional is manufactured by Implant Direct Sybron Manufacturing, LLC.
What is the FDA product code for Implant Direct Dental Implant Systems Portfolio - MR Conditional?
The FDA product code for Implant Direct Dental Implant Systems Portfolio - MR Conditional 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.