Cleared Traditional

K042971 - TITAN DENTAL IMPLANT SYSTEM

K042971 is an FDA 510(k) clearance for TITAN DENTAL IMPLANT SYSTEM, manufactured by Titan Implants, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K042971 · Titan Implants, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
78d
Days
Class 2
Risk

K042971 is an FDA 510(k) clearance for the TITAN DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Titan Implants, Inc. (San Diego, US). The FDA issued a Cleared decision on January 14, 2005 after a review of 78 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.

FDA 510(k) Submission Details - K042971

510(k) Number K042971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2004
Decision Date January 14, 2005
Days to Decision 78 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
50d faster than avg
Panel avg: 128d · This submission: 78d
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 1529
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K042971.
BICON ORTHODONTIC IMPLANT SYSTEM
K050408 · Bicon, Inc. · Apr 2005
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K043195 · Neoss, Ltd. · Mar 2005
LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)
K050257 · Mondeal Medical Systems GmbH · Feb 2005
LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)
K042345 · Mondeal Medical Systems GmbH · Jan 2005
ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320
K043226 · Imtec Corp. · Jan 2005
BICONITE SURFACE TREATMENT
K031568 · Bicon, Inc. · Nov 2004
K042971 · TITAN DENTAL IMPLANT SYSTEM
Download PDF FDA Summary Titan Implants, Inc.