OneQ-SL s-Clean Implant System
K-Number: K170220 · 2017-04-27
ApplicantDentis Co., Ltd.
Decision Date2017-04-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
OneQ-SL s-Clean Implant System is a medical device manufactured by Dentis Co., Ltd.. It received FDA 510(k) clearance on 2017-04-27 under approval number K170220. 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 OneQ-SL s-Clean Implant System?
OneQ-SL s-Clean Implant System is a medical device that received FDA 510(k) clearance on 2017-04-27. It is manufactured by Dentis Co., Ltd.. The 510(k) number is K170220.
When was OneQ-SL s-Clean Implant System approved by the FDA?
OneQ-SL s-Clean Implant System received FDA 510(k) clearance on 2017-04-27, under approval number K170220.
What company makes OneQ-SL s-Clean Implant System?
OneQ-SL s-Clean Implant System is manufactured by Dentis Co., Ltd..
What is the FDA product code for OneQ-SL s-Clean Implant System?
The FDA product code for OneQ-SL s-Clean 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.