Cleared Traditional

K013867 - XIVE DENTAL IMPLANT SYSTEM

K013867 is an FDA 510(k) clearance for XIVE DENTAL IMPLANT SYSTEM, manufactured by Friadent GmbH. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K013867 · Friadent GmbH · Dental device
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Mar 2002
Decision
114d
Days
Class 2
Risk

K013867 is an FDA 510(k) clearance for the XIVE DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Friadent GmbH (Lake Forest, US). The FDA issued a Cleared decision on March 15, 2002 after a review of 114 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 Friadent GmbH devices

FDA 510(k) Submission Details - K013867

510(k) Number K013867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2001
Decision Date March 15, 2002
Days to Decision 114 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
13d faster than avg
Panel avg: 127d · This submission: 114d
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 837
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K013867.
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