Cleared Traditional

K962014 - 3I SINGLE USE

K962014 is the FDA 510(k) clearance for 3I SINGLE USE by Implant Innovations, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K962014 · Implant Innovations, Inc. · Dental device
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Oct 1996
Decision
148d
Days
Class 2
Risk

K962014 is an FDA 510(k) clearance for the 3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC.. 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 October 18, 1996 after a review of 148 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

Submission Details

510(k) Number K962014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1996
Decision Date October 18, 1996
Days to Decision 148 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
21d slower than avg
Panel avg: 127d · This submission: 148d
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 K962014.
STERI-OSS IMPLANTS FOR SINGLE STAGE PLACEMENT
K963224 · Steri-Oss, Inc. · Nov 1996
FIXTURE MOUNT KIT
K963121 · Steri-Oss, Inc. · Nov 1996
TPS APICAL IMPLANT
K963401 · Steri-Oss, Inc. · Nov 1996
REPLACE TPS COATED IMPLANTS
K962844 · Steri-Oss, Inc. · Oct 1996
REPLACE HA COATED IMPLANTS
K962845 · Steri-Oss, Inc. · Oct 1996
ANGLED ABUTMENT
K962647 · Straumann USA · Oct 1996