Cleared Special

K024004 - XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM

K024004 is an FDA 510(k) clearance for XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM, manufactured by Friadent GmbH. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 89-day FDA review.

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

FDA 510(k) Submission Details - K024004

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Modification to existing cleared device.

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 K024004.
ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314
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