Osstem Abutment System
K-Number: K182091 · 2019-07-12
ApplicantOsstem Implant Co., Ltd.
Decision Date2019-07-12
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Osstem Abutment System is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2019-07-12 under approval number K182091. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Osstem Abutment System?
Osstem Abutment System is a medical device that received FDA 510(k) clearance on 2019-07-12. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K182091.
When was Osstem Abutment System approved by the FDA?
Osstem Abutment System received FDA 510(k) clearance on 2019-07-12, under approval number K182091.
What company makes Osstem Abutment System?
Osstem Abutment System is manufactured by Osstem Implant Co., Ltd..
What is the FDA product code for Osstem Abutment System?
The FDA product code for Osstem Abutment System is NHA.
Related Clinical Trials
Other Devices by Osstem Implant Co., Ltd.
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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.