Cleared Traditional

K010291 - ITI DENTAL IMPLANT SYSTEM

K010291 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 99-day FDA review.

K010291 · Straumann USA · Dental device
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May 2001
Decision
99d
Days
Class 2
Risk

K010291 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 May 10, 2001 after a review of 99 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 K010291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2001
Decision Date May 10, 2001
Days to Decision 99 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 127d · This submission: 99d
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 K010291.
3I LOCATER ABUTMENT SYSTEM
K012911 · Implant Innovations, Inc. · Sep 2001
ITI DENTAL IMPLANT SYSTEM
K012757 · Straumann USA · Aug 2001
LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS
K002037 · Lifecore Biomedical, Inc. · May 2001
THE MAESTRO SYSTEM
K010458 · BioHorizons Implant Systems, Inc. · May 2001
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K003271 · Institut Straumann AG · Mar 2001
THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM
K003226 · Lifecore Biomedical, Inc. · Jan 2001