MIS LYNX Conical Connection Implant System
K-Number: K251297 · 2025-07-24
ApplicantDentsply Sirona, Inc.
Decision Date2025-07-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
MIS LYNX Conical Connection Implant System is a medical device manufactured by Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2025-07-24 under approval number K251297. 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 MIS LYNX Conical Connection Implant System?
MIS LYNX Conical Connection Implant System is a medical device that received FDA 510(k) clearance on 2025-07-24. It is manufactured by Dentsply Sirona, Inc.. The 510(k) number is K251297.
When was MIS LYNX Conical Connection Implant System approved by the FDA?
MIS LYNX Conical Connection Implant System received FDA 510(k) clearance on 2025-07-24, under approval number K251297.
What company makes MIS LYNX Conical Connection Implant System?
MIS LYNX Conical Connection Implant System is manufactured by Dentsply Sirona, Inc..
What is the FDA product code for MIS LYNX Conical Connection Implant System?
The FDA product code for MIS LYNX Conical Connection 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.