Osstem Abutment System
K-Number: K221684 · 2022-09-08
ApplicantOsstem Implant Co., Ltd.
Decision Date2022-09-08
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 2022-09-08 under approval number K221684. 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 2022-09-08. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K221684.
When was Osstem Abutment System approved by the FDA?
Osstem Abutment System received FDA 510(k) clearance on 2022-09-08, under approval number K221684.
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.
Related Devices (Code: NHA)
K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.
K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG
K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A.
K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.
K161435Temporary Snap AbutmentNobel Biocare AB
K160786RODO Abutment SystemRodo Medical, Inc.
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.