Cleared Traditional

K013798 - PROSTHETIC ACCESSORIES TO THE ITI DENTA...

K013798 is the FDA 510(k) clearance for PROSTHETIC ACCESSORIES TO THE ITI DENTA... by Institut Straumann AG. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K013798 · Institut Straumann AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
34d
Days
Class 2
Risk

K013798 is an FDA 510(k) clearance for the PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Institut Straumann AG (Waltham, US). The FDA issued a Cleared decision on December 19, 2001 after a review of 34 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.

View all Institut Straumann AG devices

Submission Details

510(k) Number K013798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2001
Decision Date December 19, 2001
Days to Decision 34 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
93d faster than avg
Panel avg: 127d · This submission: 34d
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 610
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K013798.
ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM
K020096 · Institut Straumann AG · Feb 2002
SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT
K013891 · Institut Straumann AG · Feb 2002
MODIFICATION TO THE MAESTRO SYSTEM
K020133 · BioHorizons Implant Systems, Inc. · Jan 2002
OSSEOTITE DENTAL IMPLANTS
K013570 · Implant Innovations, Inc. · Dec 2001
3I LOCATER ABUTMENT SYSTEM
K012911 · Implant Innovations, Inc. · Sep 2001
ITI DENTAL IMPLANT SYSTEM
K012757 · Straumann USA · Aug 2001