Cleared Traditional

K051461 - 3I OSSEOTITE DENTAL IMPLANTS

K051461 is an FDA 510(k) clearance for 3I OSSEOTITE 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 104-day FDA review.

K051461 · Implant Innovations, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
104d
Days
Class 2
Risk

K051461 is an FDA 510(k) clearance for the 3I OSSEOTITE 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 September 15, 2005 after a review of 104 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

FDA 510(k) Submission Details - K051461

510(k) Number K051461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2005
Decision Date September 15, 2005
Days to Decision 104 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
23d faster than avg
Panel avg: 127d · This submission: 104d
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 K051461.
MILO DENTAL IMPLANT SYSTEM
K050970 · Intra-Lock International · Oct 2005
MAXIMUS 3.0 AND OS IMPLANTS
K052419 · BioHorizons Implant Systems, Inc. · Sep 2005
O.A.S.I. SYSTEM
K051552 · Lancer Orthodontics, Inc. · Sep 2005
PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS
K051614 · Lifecore Biomedical, Inc. · Sep 2005
INTERMEZZO IMPLANT SYSTEMS
K051018 · Megagen Co., Ltd. · Sep 2005
MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM
K051507 · Blue Sky Bio, LLC · Sep 2005