Cleared Special

K082213 - GS III FIXTURE SYSTEM

K082213 is the FDA 510(k) clearance for GS III FIXTURE SYSTEM by Osstem Implant Co., Ltd.. It is a Class 2 Dental device (product code DZE) cleared through the Special 510(k) pathway after a 69-day FDA review.

K082213 · Osstem Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
69d
Days
Class 2
Risk

K082213 is an FDA 510(k) clearance for the GS III FIXTURE 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 October 14, 2008 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Osstem Implant Co., Ltd. devices

Submission Details

510(k) Number K082213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2008
Decision Date October 14, 2008
Days to Decision 69 days
Submission Type Special
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
58d faster than avg
Panel avg: 127d · This submission: 69d
Pathway characteristics
Modification to existing cleared device.

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 K082213.
BIOLOK MICRO-LOK IMPLANT SYSTEM
K081818 · BioHorizons Implant Systems, Inc. · Nov 2008
MOLAR IMPLANT
K081128 · Nobel Biocare AB · Nov 2008
TEMPORARY TOOTH REPLACEMENT
K081900 · Ormco Corp. · Oct 2008
MS SYSTEM (NARROW RIDGE)
K080594 · Osstem Implant Co., Ltd. · Sep 2008
HG II FIXTURE SYSTEM
K080744 · Osstem Implant Co., Ltd. · Jul 2008
NT/IT SYSTEM
K081078 · Osstem Implant Co., Ltd. · Jul 2008