Cleared Traditional

K031055 - ITI DENTAL IMPLANT SYSTEM

K031055 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 95-day FDA review.

K031055 · Straumann USA · Dental device
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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

FDA 510(k) Submission Details - K031055

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.

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 1242
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K031055.
IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX
K031106 · Imtec Corp. · Aug 2003
OSSEOTITE NT CERTAIN IMPLANTS
K031475 · Implant Innovations, Inc. · Jul 2003
NOBEL DIRECT, MODELS 30937, 30938
K031345 · Nobel Biocare Uas, Inc. · Jul 2003
ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED
K024111 · Astra Tech, Inc. · Jun 2003
ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314
K030243 · Imtec Corp. · Apr 2003
ITI DENTAL IMPLANT SYSTEM
K030007 · Straumann USA · Mar 2003