Cleared Traditional

K072959 - MS SYSTEM (DENTURE)

K072959 is the FDA 510(k) clearance for MS SYSTEM (DENTURE) by Osstem Implant Co., Ltd.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K072959 · Osstem Implant Co., Ltd. · Dental device
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Feb 2008
Decision
108d
Days
Class 2
Risk

K072959 is an FDA 510(k) clearance for the MS SYSTEM (DENTURE). 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 February 4, 2008 after a review of 108 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 K072959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2007
Decision Date February 04, 2008
Days to Decision 108 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
19d faster than avg
Panel avg: 127d · This submission: 108d
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 K072959.
ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS
K073067 · Dentsply International, Inc. · Feb 2008
BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM
K073282 · BioHorizons Implant Systems, Inc. · Feb 2008
BIOHORIZONS INTERNAL IMPLANT SYSTEM
K073268 · BioHorizons Implant Systems, Inc. · Feb 2008
MS SYSTEM (PROVISIONAL)
K072871 · Osstem Implant Co., Ltd. · Jan 2008
NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM
K070857 · Nobel Biocare AB · Dec 2007
NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS
K072980 · Nobel Biocare AB · Dec 2007