Cleared Traditional

K983728 - LORENZ IMF SCREW

K983728 is an FDA 510(k) clearance for LORENZ IMF SCREW, manufactured by Walter Lorenz Surgical, Inc.. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K983728 · Walter Lorenz Surgical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
203d
Days
Class 2
Risk

K983728 is an FDA 510(k) clearance for the LORENZ IMF SCREW. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on May 13, 1999 after a review of 203 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4880 - 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 Walter Lorenz Surgical, Inc. devices

FDA 510(k) Submission Details - K983728

510(k) Number K983728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1998
Decision Date May 13, 1999
Days to Decision 203 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
76d slower than avg
Panel avg: 127d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZL Device Classification - Class 2, Special Controls

Product Code DZL Screw, Fixation, Intraosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4880
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 - DZL Screw, Fixation, Intraosseous

All 72
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K983728.
TALON ANCHOR SNAP-PAK
K993327 · Mitek Products · Dec 1999
MITEK MINI ANCHOR
K992623 · Mitek Products · Nov 1999
IMTEC BIOPIN
K982951 · Imtec Corp. · Jun 1999
SYNTHES 1.3 MM SELF-DRILLING SCREW
K983485 · Synthes (Usa) · Dec 1998
DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING
K981881 · Doctor'S Research Group, Inc. · Dec 1998
2.5 MM LACTOSORB SCREWS
K981666 · Biomet, Inc. · Nov 1998