Cleared Special

K093889 - MODIFICATION TO: HG III ULTRA WIDE SYSTEM

K093889 is an FDA 510(k) clearance for MODIFICATION TO: HG III ULTRA WIDE SYSTEM, manufactured by Hiossen, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 125-day FDA review.

K093889 · Hiossen, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
125d
Days
Class 2
Risk

K093889 is an FDA 510(k) clearance for the MODIFICATION TO: HG III ULTRA WIDE SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Hiossen, Inc. (Fariless Hills, US). The FDA issued a Cleared decision on April 22, 2010 after a review of 125 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K093889

510(k) Number K093889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2009
Decision Date April 22, 2010
Days to Decision 125 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
3d faster than avg
Panel avg: 128d · This submission: 125d
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 1548
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K093889.
BIODENTA DENTAL IMPLANT SYSTEM
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ZIT-Z
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M
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K093321 · BioHorizons Implant Systems, Inc. · Apr 2010
SPI DENTAL IMPLANT, ELEMENT
K093615 · Thommen Medical AG · Mar 2010
GS III SYSTEM
K091208 · Osstem Implant Co., Ltd. · Mar 2010
K093889 · MODIFICATION TO: HG III ULTRA WIDE SYSTEM
Download PDF FDA Summary Hiossen, Inc.