Cleared Traditional

K072871 - MS SYSTEM (PROVISIONAL)

K072871 is an FDA 510(k) clearance for MS SYSTEM (PROVISIONAL), 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 93-day FDA review.

K072871 · Osstem Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
93d
Days
Class 2
Risk

K072871 is an FDA 510(k) clearance for the MS SYSTEM (PROVISIONAL). Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Osstem Implant Co., Ltd. (Dunwoody, US). The FDA issued a Cleared decision on January 10, 2008 after a review of 93 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 - K072871

510(k) Number K072871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2007
Decision Date January 10, 2008
Days to Decision 93 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
34d faster than avg
Panel avg: 127d · This submission: 93d
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 1175
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K072871.
ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
K080074 · Ace Surgical Supply Co., Inc. · Feb 2008
BIOHORIZONS INTERNAL IMPLANT SYSTEM
K073268 · BioHorizons Implant Systems, Inc. · Feb 2008
MS SYSTEM (DENTURE)
K072959 · Osstem Implant Co., Ltd. · Feb 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
ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114
K072660 · Imtec Corp. · Dec 2007