Cleared Traditional

K983728 - LORENZ IMF SCREW

K983728 is the FDA 510(k) clearance for LORENZ IMF SCREW by Walter Lorenz Surgical, Inc.. It is a Class 2 Dental device (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

Submission Details

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.

Device Classification

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 41
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K983728.
LACTOSORB PUSH SCREW
K002423 · Biomet, Inc. · Oct 2000
THE AUTOTAC SYSTEM
K993493 · BioHorizons Implant Systems, Inc. · Jan 2000
KLS-MARTIN MMF SCREW
K980760 · KLS-Martin L.P. · Dec 1999
SYNTHES 1.3 MM SELF-DRILLING SCREW
K983485 · Synthes (Usa) · Dec 1998
2.5 MM LACTOSORB SCREWS
K981666 · Biomet, Inc. · Nov 1998
MEMBRANE TACK
K981459 · Biomet, Inc. · Jul 1998