Cleared Traditional

Osstem Abutment System

K221684 · Osstem Implant Co., Ltd. · Dental

Sep 2022

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K221684 is an FDA 510(k) clearance for the Osstem Abutment System, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Osstem Implant Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on September 8, 2022, 90 days after receiving the submission on June 10, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K221684 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 10, 2022
Decision Date	September 08, 2022
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NHA — Abutment, Implant, Dental, Endosseous
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3630
Definition	To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.