Osstem Abutment System

FDA 510(k) K221684 · Osstem Implant Co., Ltd.

Substantially Equivalent

510(k) numberK221684

Submission

Device name
Osstem Abutment System
Applicant
Osstem Implant Co., Ltd.
Busan, KR
Received
June 10, 2022
Decision date
September 8, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NHA – Abutment, Implant, Dental, Endosseous
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3630
Specialty
Dental
Implant
Yes

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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More from Hiossen, Inc.

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K251434Healing Abutment SystemNHA · Traditional 03/04/2026SE
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K233806T2 PlusOAS · Traditional 09/06/2024SE
K233194TS Abutment SystemNHA · Traditional 02/20/2024SE
K232220SS Abutment SystemNHA · Traditional 12/05/2023SE
K232012N1EHD · Traditional 11/28/2023SE
K222778Osstem Implant SystemDZE · Traditional 09/23/2023SE
K212303T2OAS · Traditional 09/21/2021SE
K210097Estar-ZEIH · Traditional 07/02/2021SE

Questions and answers

When was Osstem Abutment System cleared by the FDA?

Osstem Abutment System (K221684) received a 510(k) decision of Substantially Equivalent on September 8, 2022, 90 days after the submission was received.

What is the product code of K221684?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.