ET III Bio-SA Fixture System
K-Number: K151626 · 2016-07-21
ApplicantHiossen, Inc.
Decision Date2016-07-21
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ET III Bio-SA Fixture System is a medical device manufactured by Hiossen, Inc.. It received FDA 510(k) clearance on 2016-07-21 under approval number K151626. 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 ET III Bio-SA Fixture System?
ET III Bio-SA Fixture System is a medical device that received FDA 510(k) clearance on 2016-07-21. It is manufactured by Hiossen, Inc.. The 510(k) number is K151626.
When was ET III Bio-SA Fixture System approved by the FDA?
ET III Bio-SA Fixture System received FDA 510(k) clearance on 2016-07-21, under approval number K151626.
What company makes ET III Bio-SA Fixture System?
ET III Bio-SA Fixture System is manufactured by Hiossen, Inc..
What is the FDA product code for ET III Bio-SA Fixture System?
The FDA product code for ET III Bio-SA Fixture System is DZE.
Other Devices by Hiossen, Inc.
Related Devices (Code: DZE)
K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG
K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd.
K163043Zeramex P6 Dental Implant SystemDentalpoint AG
K161497Dental Implants and AbutmentsDitron Precision, Ltd.
K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.
K151970KJ Mini Implant SystemKj Meditech Co., Ltd.
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.