Cleared Special

XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM (K024004) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K024004 · Friadent GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
89d
Days
Class 2
Risk

K024004 is an FDA 510(k) clearance for the XIVE TRANSGINGIVAL 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 3, 2003 after a review of 89 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 Friadent GmbH devices

Submission Details

510(k) Number K024004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2002
Decision Date March 03, 2003
Days to Decision 89 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 127d · This submission: 89d
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 303
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K024004.
TREFOIL System
K172352 · Nobel Biocare AB · Oct 2017
TREFOIL System
K170135 · Nobel Biocare AB · May 2017
NobelZygoma 0°
K161598 · Nobel Biocare AB · Mar 2017
DENTSPLY PRECISION TORQUE SYSTEM
K964046 · Dentsply Intl. · Mar 1997
LORENZ SURGICAL THREADED DENTAL IMPLANT
K941619 · Biomet, Inc. · Sep 1994
LORENZ SURGICAL CYLINDER DENTAL IMPLANT
K941620 · Biomet, Inc. · Sep 1994