TSIII BA Fixture
K-Number: K163088 · 2017-04-21
ApplicantOsstem Implant Co., Ltd.
Decision Date2017-04-21
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TSIII BA Fixture is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2017-04-21 under approval number K163088. 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 TSIII BA Fixture?
TSIII BA Fixture is a medical device that received FDA 510(k) clearance on 2017-04-21. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K163088.
When was TSIII BA Fixture approved by the FDA?
TSIII BA Fixture received FDA 510(k) clearance on 2017-04-21, under approval number K163088.
What company makes TSIII BA Fixture?
TSIII BA Fixture is manufactured by Osstem Implant Co., Ltd..
What is the FDA product code for TSIII BA Fixture?
The FDA product code for TSIII BA Fixture is DZE.
Other Devices by Osstem Implant Co., Ltd.
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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.