Cleared Traditional

K003191 - MIS IMPLANT SYSTEM DECIVE

K003191 is the FDA 510(k) clearance for MIS IMPLANT SYSTEM DECIVE by Mis Implants Technologies , Ltd.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 353-day FDA review.

K003191 · Mis Implants Technologies , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
353d
Days
Class 2
Risk

K003191 is an FDA 510(k) clearance for the MIS IMPLANT SYSTEM DECIVE. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Mis Implants Technologies , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on September 28, 2001 after a review of 353 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Mis Implants Technologies , Ltd. devices

Submission Details

510(k) Number K003191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2000
Decision Date September 28, 2001
Days to Decision 353 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 127d · This submission: 353d
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 589
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K003191.
MODIFICATION TO THE MAESTRO SYSTEM
K020133 · BioHorizons Implant Systems, Inc. · Jan 2002
PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
K013798 · Institut Straumann AG · Dec 2001
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
ITI DENTAL IMPLANT SYSTEM
K010291 · Straumann USA · May 2001