Cleared Traditional

K091878 - OSSEOLINK DENTAL IMPLANT SYSTEM

K091878 is an FDA 510(k) clearance for OSSEOLINK DENTAL IMPLANT SYSTEM, manufactured by Global Implant Solutions, LLC. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K091878 · Global Implant Solutions, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
105d
Days
Class 2
Risk

K091878 is an FDA 510(k) clearance for the OSSEOLINK DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Global Implant Solutions, LLC (Austin, US). The FDA issued a Cleared decision on October 6, 2009 after a review of 105 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.

FDA 510(k) Submission Details - K091878

510(k) Number K091878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2009
Decision Date October 06, 2009
Days to Decision 105 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
23d faster than avg
Panel avg: 128d · This submission: 105d
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 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K091878.
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ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX
K092594 · Ace Surgical Supply Co., Inc. · Sep 2009
K091878 · OSSEOLINK DENTAL IMPLANT SYSTEM
Download PDF FDA Summary Global Implant Soluti…