Cleared Traditional

K962014 - 3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC.

K962014 is an FDA 510(k) clearance for 3I SINGLE USE, 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 148-day FDA review.

K962014 · Implant Innovations, Inc. · Dental device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K962014

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.

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 1187
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
DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES
K962610 · Implant Integration Systems, Inc. · Oct 1996
REPLACE TPS COATED IMPLANTS
K962844 · Steri-Oss, Inc. · Oct 1996
REPLACE HA COATED IMPLANTS
K962845 · Steri-Oss, Inc. · Oct 1996