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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
38d faster than avg
Panel avg: 128d · 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 1546
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K081078.
RESCUE EXTERNAL IMPLANT SYSTEM
K081302 · Megagen Implant Co., Ltd. · Aug 2008
HG II FIXTURE SYSTEM
K080744 · Osstem Implant Co., Ltd. · Jul 2008
SCREWINDIRECT DENTAL IMPLANTS
K080633 · Implant Direct, LLC · Jul 2008
KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK
K080224 · SOADCO, S.L. · Jul 2008
I-MINI DENTAL IMPLANT
K080115 · Oco Biomedical · May 2008
SECURE IMPLANT SYSTEM (2.5/3.0MM)
K080129 · Dio Department Dsi, Inc. · May 2008
K081078 · NT/IT SYSTEM
Download PDF FDA Summary Osstem Implant Co., L…