Cleared Traditional

K081078 - NT/IT SYSTEM

K081078 is an FDA 510(k) clearance for NT/IT 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 90-day FDA review.

K081078 · Osstem Implant Co., Ltd. · Dental device
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Jul 2008
Decision
90d
Days
Class 2
Risk

K081078 is an FDA 510(k) clearance for the NT/IT 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 July 15, 2008 after a review of 90 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 - K081078

510(k) Number K081078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2008
Decision Date July 15, 2008
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
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 K081078.
MS SYSTEM (NARROW RIDGE)
K080594 · Osstem Implant Co., Ltd. · Sep 2008
RESCUE EXTERNAL IMPLANT SYSTEM
K081302 · Megagen Implant Co., Ltd. · Aug 2008
HG II FIXTURE SYSTEM
K080744 · Osstem Implant Co., Ltd. · Jul 2008
US/GS ULTRA WIDE SYSTEM
K073465 · Osstem Implant Co., Ltd. · Apr 2008
DENTIS DENTAL IMPLANT SYSTEM
K073486 · Dentis Co., Ltd. · Apr 2008
FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS
K073075 · Dentsply International, Inc. · Mar 2008