Cleared Traditional

K063341 - 3I OSSEOTITE CERTAIN DENTAL IMPLANTS

K063341 is an FDA 510(k) clearance for 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 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 175-day FDA review.

K063341 · Implant Innovations, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
175d
Days
Class 2
Risk

K063341 is an FDA 510(k) clearance for the 3I OSSEOTITE CERTAIN DENTAL 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 April 30, 2007 after a review of 175 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.

FDA 510(k) Submission Details - K063341

510(k) Number K063341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2006
Decision Date April 30, 2007
Days to Decision 175 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
47d slower than avg
Panel avg: 128d · This submission: 175d
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 K063341.
DIO PROTEM IMPLANT SYSTEM
K070568 · Dio Department Dsi, Inc. · May 2007
ENDOSSEOUS DENTAL IMPLANT SYSTEM
K070905 · Southern Implants, Inc. · May 2007
MODIFICATION TO RELIADENT DENTAL IMPLANT SYSTEM
K061323 · Bioinfera, Inc. · May 2007
OSSEOSPEED 4.0S-6MM, MODEL 24619
K063779 · Astra Tech, Inc. · Apr 2007
OSSEOTITE
K063286 · Implant Innovations, Inc. · Apr 2007
MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9
K070022 · Mis Implants Technologies , Ltd. · Apr 2007
K063341 · 3I OSSEOTITE CERTAIN DENTAL IMPLANTS
Download PDF FDA Summary Implant Innovations, …