Cleared Traditional

K983742 - ITI DENTAL IMPLANT SYSTEM

K983742 is an FDA 510(k) clearance for ITI DENTAL IMPLANT SYSTEM, manufactured by Institut Straumann AG. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K983742 · Institut Straumann AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
143d
Days
Class 2
Risk

K983742 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 Institut Straumann AG (Waltham, US). The FDA issued a Cleared decision on March 15, 1999 after a review of 143 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 Institut Straumann AG devices

FDA 510(k) Submission Details - K983742

510(k) Number K983742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1998
Decision Date March 15, 1999
Days to Decision 143 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
16d slower than avg
Panel avg: 127d · This submission: 143d
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 1188
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K983742.
MODIFICATION TO IMTEC SENDAX MDI
K990983 · Imtec Corp. · Apr 1999
O-RING ABUTMENT
K990277 · BioHorizons Implant Systems, Inc. · Apr 1999
ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW
K981858 · Atlantis Components, Inc. · Mar 1999
PROVISIONAL DENTAL IMPLANT SYSTEM
K984287 · Nobel Biocare Uas, Inc. · Mar 1999
WIDE BODY ABUTMENTS
K984198 · Vident · Feb 1999
BICON BONE SCREW SYSTEM
K982488 · Bicon, Inc. · Jan 1999