Cleared Traditional

K073465 - US/GS ULTRA WIDE SYSTEM

K073465 is an FDA 510(k) clearance for US/GS ULTRA WIDE SYSTEM, manufactured by Osstem Implant Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K073465 · Osstem Implant Co., Ltd. · Dental device
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Apr 2008
Decision
119d
Days
Class 2
Risk

K073465 is an FDA 510(k) clearance for the US/GS ULTRA WIDE SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Osstem Implant Co., Ltd. (Fairless Hills, US). The FDA issued a Cleared decision on April 7, 2008 after a review of 119 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Osstem Implant Co., Ltd. devices

FDA 510(k) Submission Details - K073465

510(k) Number K073465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2007
Decision Date April 07, 2008
Days to Decision 119 days
Submission Type Traditional
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
8d faster than avg
Panel avg: 127d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1174
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K073465.
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HG II FIXTURE SYSTEM
K080744 · Osstem Implant Co., Ltd. · Jul 2008
NT/IT SYSTEM
K081078 · Osstem Implant Co., Ltd. · Jul 2008
DENTIS DENTAL IMPLANT SYSTEM
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FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS
K073075 · Dentsply International, Inc. · Mar 2008
BLUE SKY BIO DENTAL IMPLANT SYSTEM
K073713 · Blue Sky Bio, LLC · Mar 2008