Cleared Traditional

K962394 - IMPLANT INTEGRATION SYSTEMS DRILLS AND TAPS

K962394 is an FDA 510(k) clearance for IMPLANT INTEGRATION SYSTEMS DRILLS AND TAPS, manufactured by Implant Integration Systems, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K962394 · Implant Integration Systems, Inc. · Dental device
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Oct 1996
Decision
113d
Days
Class 2
Risk

K962394 is an FDA 510(k) clearance for the IMPLANT INTEGRATION SYSTEMS DRILLS AND TAPS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Implant Integration Systems, Inc. (Paradise, US). The FDA issued a Cleared decision on October 11, 1996 after a review of 113 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 Integration Systems, Inc. devices

FDA 510(k) Submission Details - K962394

510(k) Number K962394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1996
Decision Date October 11, 1996
Days to Decision 113 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 127d · This submission: 113d
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 941
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K962394.
3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC.
K962014 · Implant Innovations, Inc. · Oct 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
TIL313 ABUTMENT AND RETAINING SCREW SYSTEMS
K962465 · Implant Innovations, Inc. · Sep 1996
NOBLEPHARMA WIDE ACCESSORIES
K962403 · Nobelpharma USA, Inc. · Sep 1996