Cleared Traditional

K010291 - ITI DENTAL IMPLANT SYSTEM

K010291 is an FDA 510(k) clearance for ITI DENTAL IMPLANT SYSTEM, manufactured by Straumann USA. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K010291

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.

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 1241
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K010291.
ITI DENTAL IMPLANT SYSTEM
K012757 · Straumann USA · Aug 2001
ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH
K991822 · Dr. Ihde Dental AG Switzerland · 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
ACE SDS 3.75MM SCREW DENTAL IMPLANT
K002075 · Ace Surgical Supply Co., Inc. · Feb 2001