Cleared Special

K5 Cart, K5 Mount, K5 Swing

K251491 · Osstem Implant Company., Ltd. Chair Business · Dental

Jul 2025

Decision

64d

Days

Class 1

Risk

About This 510(k) Submission

K251491 is an FDA 510(k) clearance for the K5 Cart, K5 Mount, K5 Swing, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Osstem Implant Company., Ltd. Chair Business (Ansan-Si, KR). The FDA issued a Cleared decision on July 17, 2025, 64 days after receiving the submission on May 14, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number	K251491 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 2025
Decision Date	July 17, 2025
Days to Decision	64 days
Submission Type	Special
Review Panel	Dental (DE)
Summary	Summary PDF