Cleared Traditional

K083067 - MS SYSTEM

K083067 is the FDA 510(k) clearance for MS SYSTEM by Osstem Implant Co., Ltd.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K083067 · Osstem Implant Co., Ltd. · Dental device
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Feb 2009
Decision
110d
Days
Class 2
Risk

K083067 is an FDA 510(k) clearance for the MS SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Osstem Implant Co., Ltd. (Fariless Hills, US). The FDA issued a Cleared decision on February 2, 2009 after a review of 110 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

Submission Details

510(k) Number K083067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2008
Decision Date February 02, 2009
Days to Decision 110 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
17d faster than avg
Panel avg: 127d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 581
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K083067.
STRAUMANN DENTAL IMPLANT SYSTEM
K083550 · Straumann USA · Feb 2009
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K081419 · Institut Straumann AG · Feb 2009
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K083205 · Nobel Biocare AB · Feb 2009
ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS
K082639 · Zimmer Dental, Inc. · Dec 2008
BIOLOK MICRO-LOK IMPLANT SYSTEM
K081818 · BioHorizons Implant Systems, Inc. · Nov 2008
MOLAR IMPLANT
K081128 · Nobel Biocare AB · Nov 2008