Cleared Traditional

Osstem Abutment System

K182091 · Osstem Implant Co., Ltd. · Dental

Jul 2019

Decision

343d

Days

Class 2

Risk

About This 510(k) Submission

K182091 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 July 12, 2019, 343 days after receiving the submission on August 3, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K182091 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 03, 2018
Decision Date	July 12, 2019
Days to Decision	343 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.