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Lorenz Resorbable Distraction System or Expander

by Walter Lorenz Surgical, Inc. 510(k)

Active United States

510(k) K030425

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK030425 Date14 May 2004ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JEY
Device Class
Class II
Regulation
21 CFR Part 872.4760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Lorenz Resorbable Distraction System or Expander is a bone plate device intended for use in bone stabilization and elongation, including correction of oral (alveolar ridge), cranial, and maxillofacial deficiencies or post-traumatic defects requiring gradual bone correction. It is classified as a Class 2 medical device under FDA regulation number 872.4760 with product code JEY and falls within the dental medical specialty.

The device received FDA 510(k) clearance (K030425) on May 14, 2004, following a traditional review process, and is substantially equivalent to a legally marketed predicate device. It is manufactured by Walter Lorenz Surgical, Inc. and is supplied as a non-sterile, reusable device for use in dental and maxillofacial surgical settings.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Lorenz Resorbable Distraction System or Expander used for?

    It is intended for bone stabilization and elongation, including correction of oral alveolar ridge, cranial, and maxillofacial deficiencies or post-traumatic defects requiring gradual bone correction.

  • How is the Lorenz Resorbable Distraction System or Expander supplied and is it sterile?

    The device is supplied as a non-sterile, reusable device for use in dental and maxillofacial surgical settings, requiring cleaning and sterilization by the user before each use.

  • What regulatory pathway was used for the Lorenz Resorbable Distraction System or Expander?

    It received FDA 510(k) clearance (K030425) on May 14, 2004, through a traditional review process and is substantially equivalent to a legally marketed predicate device.