Cleared Traditional

K031055 - ITI DENTAL IMPLANT SYSTEM

K031055 is the FDA 510(k) clearance for ITI DENTAL IMPLANT SYSTEM by Straumann USA. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K031055 · Straumann USA · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
95d
Days
Class 2
Risk

K031055 is an FDA 510(k) clearance for the ITI DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Straumann USA (Waltham, US). The FDA issued a Cleared decision on July 7, 2003 after a review of 95 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 Straumann USA devices

Submission Details

510(k) Number K031055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2003
Decision Date July 07, 2003
Days to Decision 95 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
32d faster than avg
Panel avg: 127d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 672
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K031055.
3I DENTAL IMPLANTS
K030614 · Implant Innovations, Inc. · Sep 2003
OSSEOTITE NT CERTAIN IMPLANTS
K031475 · Implant Innovations, Inc. · Jul 2003
NOBEL DIRECT, MODELS 30937, 30938
K031345 · Nobel Biocare Uas, Inc. · Jul 2003
ITI DENTAL IMPLANT SYSTEM
K030007 · Straumann USA · Mar 2003
MODIFICATION TO THE MAESTRO SYSTEM
K030463 · BioHorizons Implant Systems, Inc. · Feb 2003
NOBEL PERFECT IMPLANT SYSTEM
K030257 · Nobel Biocare Uas, Inc. · Feb 2003