Cleared Traditional

K032263 - 3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR

K032263 is an FDA 510(k) clearance for 3I PATIENT-SPECIFIC DENTAL ABUTMENT AND..., 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 189-day FDA review.

K032263 · Implant Innovations, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K032263

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.

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 1185
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K032263.
SPI CONTACT DENTAL IMPLANT
K034014 · Thommen Medical AG · Mar 2004
DUAL TOP ANCHOR SYSTEM SCREWS
K033767 · Jeil Medical Corporation · Feb 2004
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
OSTEOMED ORTHODONTIC SCREW SYSTEM
K031936 · Osteomed LP · Jan 2004
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K033922 · Institut Straumann AG · Jan 2004