Cleared Special

K160363 - OPTIMUS CMF SYSTEM

K160363 is an FDA 510(k) clearance for OPTIMUS CMF SYSTEM, manufactured by Osteonic Co., Ltd.. The device is a Class 2 Dental device with product code JEY cleared through the Special 510(k) pathway after a 254-day FDA review.

K160363 · Osteonic Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
254d
Days
Class 2
Risk

K160363 is an FDA 510(k) clearance for the OPTIMUS CMF SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Osteonic Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on October 20, 2016 after a review of 254 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K160363

510(k) Number K160363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2016
Decision Date October 20, 2016
Days to Decision 254 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
126d slower than avg
Panel avg: 128d · This submission: 254d
Pathway characteristics
Modification to existing cleared device.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

LK Consulting Group USA, Inc.
Priscilla Chung

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.

Regulatory Peers - JEY Plate, Bone

All 293
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K160363 · OPTIMUS CMF SYSTEM
Download PDF FDA Summary Osteonic Co., Ltd.