Cleared Traditional

K963495 - IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM

K963495 is an FDA 510(k) clearance for IMZ 2000 INTERLOCK 12/3 - CYLINDER DENT..., manufactured by Imz, GmbH. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K963495 · Imz, GmbH · Dental device
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Mar 1997
Decision
181d
Days
Class 2
Risk

K963495 is an FDA 510(k) clearance for the IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Imz, GmbH (Potomac, US). The FDA issued a Cleared decision on March 3, 1997 after a review of 181 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 Imz, GmbH devices

FDA 510(k) Submission Details - K963495

510(k) Number K963495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date March 03, 1997
Days to Decision 181 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 127d · This submission: 181d
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 1047
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K963495.
SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ABUTMENT ) FOR SINGLE OOTH CEMENT RETAINED RESTORATIONS
K965077 · Implant Innovations, Inc. · Mar 1997
REPLACE TITANIUM IMPLANT SYSTEM
K964220 · Steri-Oss, Inc. · Mar 1997
DENTSPLY PRECISION TORQUE SYSTEM
K964046 · Dentsply Intl. · Mar 1997
IMZ 2000 INTERLOCK 12/3 - SCREW
K963522 · Imz, GmbH · Mar 1997
THREADLOC DENTAL IMPLANT SYSTEMS
K964768 · Sulzer Calcitek, Inc. · Feb 1997
LIFECORE CONICAL ABUTMENT
K965135 · Lifecore Biomedical, Inc. · Feb 1997