Cleared Special

K251491 - K5 Cart, K5 Mount, K5 Swing (FDA 510(k) Clearance)

Class I Dental device.

K251491 · Osstem Implant Company., Ltd. Chair Business · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
64d
Days
Class 1
Risk

K251491 is an FDA 510(k) clearance for the K5 Cart, K5 Mount, K5 Swing. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Osstem Implant Company., Ltd. Chair Business (Ansan-Si, KR). The FDA issued a Cleared decision on July 17, 2025 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Osstem Implant Company., Ltd. Chair Business devices

Submission Details

510(k) Number K251491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 127d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Hiossen, Inc.
Leszczak Mateusz

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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