Cleared Traditional

K954347 - 3I STANDARD THREADED IMPLANT

K954347 is the FDA 510(k) clearance for 3I STANDARD THREADED IMPLANT by Implant Innovations, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K954347 · Implant Innovations, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
196d
Days
Class 2
Risk

K954347 is an FDA 510(k) clearance for the 3I STANDARD THREADED IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Implant Innovations, Inc. (West Palm Baeach, US). The FDA issued a Cleared decision on April 1, 1996 after a review of 196 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 K954347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1995
Decision Date April 01, 1996
Days to Decision 196 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
69d slower than avg
Panel avg: 127d · This submission: 196d
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 K954347.
STERI-OSS 6MM DIAMETER TPS COATED IMPLANTS
K961020 · Steri-Oss, Inc. · Jun 1996
SCREW EXTRACTION DEVICE AND THREAD CLEANING TAP
K960979 · Steri-Oss, Inc. · May 1996
ABUTMENT SELECTION KIT
K960639 · Nobelpharma USA, Inc. · May 1996
BIOHORIZONS DENTAL IMPLANT SYSTEM
K960026 · BioHorizons Implant Systems, Inc. · Mar 1996
3I TITANIUM PLASMA SPRAYED STANDARD THREADED & SELF-TAPPING IMPLANTS
K955427 · Implant Innovations, Inc. · Feb 1996
3I HYDROXYLAPATITE COATED STANDARD THREADED & SELF-TAPPING IMPLANTS
K955428 · Implant Innovations, Inc. · Feb 1996