s-Clean Tapered II RBM Implant System
K-Number: K160213 · 2016-06-21
ApplicantDentis Co., Ltd.
Decision Date2016-06-21
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
s-Clean Tapered II RBM Implant System is a medical device manufactured by Dentis Co., Ltd.. It received FDA 510(k) clearance on 2016-06-21 under approval number K160213. 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 s-Clean Tapered II RBM Implant System?
s-Clean Tapered II RBM Implant System is a medical device that received FDA 510(k) clearance on 2016-06-21. It is manufactured by Dentis Co., Ltd.. The 510(k) number is K160213.
When was s-Clean Tapered II RBM Implant System approved by the FDA?
s-Clean Tapered II RBM Implant System received FDA 510(k) clearance on 2016-06-21, under approval number K160213.
What company makes s-Clean Tapered II RBM Implant System?
s-Clean Tapered II RBM Implant System is manufactured by Dentis Co., Ltd..
What is the FDA product code for s-Clean Tapered II RBM Implant System?
The FDA product code for s-Clean Tapered II RBM 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.