Cleared Traditional

K031632 - OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS

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

K031632 · Implant Innovations, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K031632

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
16d faster than avg
Panel avg: 128d · This submission: 112d
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 1547
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K031632.
XIVE TG ABUTMENTS
K032302 · Friadent GmbH · Oct 2003
MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE
K032750 · Friandent GmbH · Oct 2003
THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM
K032495 · Lifecore Biomedical, Inc. · Sep 2003
3I DENTAL IMPLANTS
K030614 · Implant Innovations, Inc. · Sep 2003
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM
K022258 · B.T.I. Biotechnology Institute, Sl. · Sep 2003
ANKYLOS
K012681 · Dentsply Ceramco · Aug 2003
K031632 · OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS
Download PDF FDA Summary Implant Innovations, …