Lorenz Self-Drilling IMF Screw
by Walter Lorenz Surgical, Inc. 510(k)
Active
510(k) K040983
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040983 | Date5 May 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DZE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Lorenz Self-Drilling IMF Screw is a 2.0mm diameter bone screw used for temporary maxillomandibular fixation, providing indirect stabilization of maxillary and mandibular fractures. It features a head with a relief groove, optionally including a hole for wrapping wire or elastic bands.
The device is implanted into bone during surgical procedures by clinicians. It is supplied as a single-use implant and is authorized under FDA 510(k) clearance K040983 with product code DZE. It is classified as a Class 2 Dental device.
Other devices from Walter Lorenz Surgical, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the Lorenz Self-Drilling IMF Screw used for?
It is used for temporary maxillomandibular fixation to provide indirect stabilization of maxillary and mandibular fractures during surgical procedures, as it is implanted into bone by clinicians.
How is the Lorenz Self-Drilling IMF Screw supplied and is it reusable?
It is supplied as a single-use implant, meaning it is intended for one-time use only and should not be reused after implantation to ensure patient safety and device integrity.
What are the key physical characteristics of the Lorenz Self-Drilling IMF Screw?
The device has a 2.0mm diameter and features a head with a relief groove, which may optionally include a hole for wrapping wire or elastic bands to aid in fixation during surgery.