Cleared Traditional

K032263 - 3I PATIENT-SPECIFIC DENTAL ABUTMENT AND...

K032263 is the FDA 510(k) clearance for 3I PATIENT-SPECIFIC DENTAL ABUTMENT AND... by Implant Innovations, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K032263 · Implant Innovations, Inc. · Dental device
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Jan 2004
Decision
189d
Days
Class 2
Risk

K032263 is an FDA 510(k) clearance for the 3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR. 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 January 28, 2004 after a review of 189 days - an extended review 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: 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 K032263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2003
Decision Date January 28, 2004
Days to Decision 189 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
62d slower than avg
Panel avg: 127d · This submission: 189d
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 K032263.
LORENZ SELF-DRILLING IMF SCREW
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DUAL TOP ANCHOR SYSTEM SCREWS
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TEETH IN AN HOUR - ARK IMPLANT CONCEPT
K030685 · Nobel Biocare AB · Feb 2004
KLS-MARTIN ORTHO ANCHORAGE SYSTEM
K033483 · KLS-Martin L.P. · Jan 2004
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
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