Cleared Traditional

K032302 - XIVE TG ABUTMENTS

K032302 is an FDA 510(k) clearance for XIVE TG ABUTMENTS, 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 69-day FDA review.

K032302 · Friadent GmbH · Dental device
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Oct 2003
Decision
69d
Days
Class 2
Risk

K032302 is an FDA 510(k) clearance for the XIVE TG ABUTMENTS. 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 October 2, 2003 after a review of 69 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Friadent GmbH devices

FDA 510(k) Submission Details - K032302

510(k) Number K032302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2003
Decision Date October 02, 2003
Days to Decision 69 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
58d faster than avg
Panel avg: 127d · This submission: 69d
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
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