Cleared Special

K160106 - LUNA DENTAL IMPLANT SYSTEM

K160106 is an FDA 510(k) clearance for LUNA DENTAL IMPLANT SYSTEM, manufactured by Shinhung Mst Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 220-day FDA review.

K160106 · Shinhung Mst Co., Ltd. · Dental device
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Aug 2016
Decision
220d
Days
Class 2
Risk

K160106 is an FDA 510(k) clearance for the LUNA DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Shinhung Mst Co., Ltd. (Wonju-Si, KR). The FDA issued a Cleared decision on August 26, 2016 after a review of 220 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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.

View all Shinhung Mst Co., Ltd. devices

FDA 510(k) Submission Details - K160106

510(k) Number K160106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2016
Decision Date August 26, 2016
Days to Decision 220 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 128d · This submission: 220d
Pathway characteristics
Modification to existing cleared device.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 Peers - DZE Implant, Endosseous, Root-form

All 1376
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K160106.
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