Cleared Traditional

K031632 - OSSEOTITE IOL IMPLANTS AND OSSEOTITE CE...

K031632 is the FDA 510(k) clearance for OSSEOTITE IOL IMPLANTS AND OSSEOTITE CE... by Implant Innovations, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K031632 · Implant Innovations, Inc. · Dental device
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Sep 2003
Decision
112d
Days
Class 2
Risk

K031632 is an FDA 510(k) clearance for the OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Implant Innovations, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on September 16, 2003 after a review of 112 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 Implant Innovations, Inc. devices

Submission Details

510(k) Number K031632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2003
Decision Date September 16, 2003
Days to Decision 112 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
15d faster than avg
Panel avg: 127d · This submission: 112d
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 588
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K031632.
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K033922 · Institut Straumann AG · Jan 2004
3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615
K033430 · Implant Innovations, Inc. · Nov 2003
THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT
K032351 · BioHorizons Implant Systems, Inc. · Oct 2003
3I DENTAL IMPLANTS
K030614 · Implant Innovations, Inc. · Sep 2003
OSSEOTITE NT CERTAIN IMPLANTS
K031475 · Implant Innovations, Inc. · Jul 2003
ITI DENTAL IMPLANT SYSTEM
K031055 · Straumann USA · Jul 2003