SS SA Fixture
K-Number: K163557 · 2017-05-15
ApplicantOsstem Implant Co., Ltd.
Decision Date2017-05-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SS SA Fixture is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2017-05-15 under approval number K163557. 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 SS SA Fixture?
SS SA Fixture is a medical device that received FDA 510(k) clearance on 2017-05-15. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K163557.
When was SS SA Fixture approved by the FDA?
SS SA Fixture received FDA 510(k) clearance on 2017-05-15, under approval number K163557.
What company makes SS SA Fixture?
SS SA Fixture is manufactured by Osstem Implant Co., Ltd..
What is the FDA product code for SS SA Fixture?
The FDA product code for SS SA Fixture is DZE.
Other Devices by Osstem Implant Co., Ltd.
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.