MIS Dental Implant System
K-Number: K200102 · 2020-09-03
ApplicantDentsply Sirona
Decision Date2020-09-03
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
MIS Dental Implant System is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2020-09-03 under approval number K200102. 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 Dental Implant System?
MIS Dental Implant System is a medical device that received FDA 510(k) clearance on 2020-09-03. It is manufactured by Dentsply Sirona. The 510(k) number is K200102.
When was MIS Dental Implant System approved by the FDA?
MIS Dental Implant System received FDA 510(k) clearance on 2020-09-03, under approval number K200102.
What company makes MIS Dental Implant System?
MIS Dental Implant System is manufactured by Dentsply Sirona.
What is the FDA product code for MIS Dental Implant System?
The FDA product code for MIS Dental 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.