Cleared Special

K093352 - HG III FIXTURE SYSTEM

K093352 is an FDA 510(k) clearance for HG III FIXTURE 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 28-day FDA review.

K093352 · Hiossen, Inc. · Dental device
Download Printable Device Report (PDF)
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Nov 2009
Decision
28d
Days
Class 2
Risk

K093352 is an FDA 510(k) clearance for the HG III FIXTURE 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 November 24, 2009 after a review of 28 days - a notably fast clearance 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. 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 Hiossen, Inc. devices

FDA 510(k) Submission Details - K093352

510(k) Number K093352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2009
Decision Date November 24, 2009
Days to Decision 28 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
99d faster than avg
Panel avg: 127d · This submission: 28d
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.

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All 1185
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