Cleared Special

K040983 - LORENZ SELF-DRILLING IMF SCREW

K040983 is an FDA 510(k) clearance for LORENZ SELF-DRILLING IMF SCREW, manufactured by Walter Lorenz Surgical, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 20-day FDA review.

K040983 · Walter Lorenz Surgical, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
20d
Days
Class 2
Risk

K040983 is an FDA 510(k) clearance for the LORENZ SELF-DRILLING IMF SCREW. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on May 5, 2004 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K040983

510(k) Number K040983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2004
Decision Date May 05, 2004
Days to Decision 20 days
Submission Type Special
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
108d faster than avg
Panel avg: 128d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 1547
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K040983.
MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS
K041402 · Implant Innovations, Inc. · Jun 2004
MIS DENTAL IMPLANT SYSTEM
K040807 · Mis - Implant Technologies , Ltd. · Jun 2004
KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES)
K040891 · KLS-Martin L.P. · May 2004
NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING
K033171 · Northern Implants, LLC · Apr 2004
LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586
K033699 · Zest Anchors, Inc. · Apr 2004
MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK
K033630 · Rhein 83 Srl · Apr 2004
K040983 · LORENZ SELF-DRILLING IMF SCREW
Download PDF FDA Summary Walter Lorenz Surgica…