Cleared Traditional

K063861 - GS SYSTEM

K063861 is the FDA 510(k) clearance for GS 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 267-day FDA review.

K063861 · Osstem Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
267d
Days
Class 2
Risk

K063861 is an FDA 510(k) clearance for the GS SYSTEM. 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 September 21, 2007 after a review of 267 days - an extended review cycle.

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 K063861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2006
Decision Date September 21, 2007
Days to Decision 267 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
140d slower than avg
Panel avg: 127d · This submission: 267d
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 K063861.
GS FIXTURE SYSTEM
K072896 · Osstem Implant Co., Ltd. · Nov 2007
BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM
K071638 · BioHorizons Implant Systems, Inc. · Oct 2007
TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16
K072589 · Zimmer Dental, Inc. · Oct 2007
ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM
K071439 · Zimmer Dental, Inc. · Sep 2007
NOBELACTIVE INTERNAL CONNECTION IMPLANT
K071370 · Nobel Biocare AB · Aug 2007
OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS
K062636 · Implant Innovations, Inc. · Jun 2007