Cleared Traditional

Bone Screw, Bone Tack

K182881 · Osstem Implant Co., Ltd. · Dental
Aug 2019
Decision
298d
Days
Class 2
Risk

About This 510(k) Submission

K182881 is an FDA 510(k) clearance for the Bone Screw, Bone Tack, a Screw, Fixation, Intraosseous (Class II — Special Controls, product code DZL), submitted by Osstem Implant Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on August 9, 2019, 298 days after receiving the submission on October 15, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.4880.

Submission Details

510(k) Number K182881 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2018
Decision Date August 09, 2019
Days to Decision 298 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZL — Screw, Fixation, Intraosseous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4880

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