Add-on Condyle

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K002790 ↗

FDA Product Code

NEI

Device Class

Class II

Regulation

21 CFR Part 872.4770

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• Lorenz External Mandibular Distractor

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• Steinhauser Titanium Mini Bone Plates & Screws

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• Lorenz Pectus Support Bar

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• Lorenz Maxilla (Le Fort) Distraction System

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See all devices from Walter Lorenz Surgical, Inc. →

• What is the ADD-ON CONDYLE used for?

  The ADD-ON CONDYLE is a temporary mandibular condyle prosthesis used in dental procedures. It serves as a replacement for the mandibular condyle during treatment, providing temporary functionality while permanent solutions are being prepared or implemented.

• How is the ADD-ON CONDYLE supplied and what are its sterility requirements?

  The device is supplied as a sterile product, though the specific sterilization method is not detailed in the provided information. It is classified as a dental prosthesis under regulation number 872.4770, indicating it meets specific manufacturing and safety standards for dental applications.

• Is the ADD-ON CONDYLE reusable or single-use?

  The provided information does not specify whether the ADD-ON CONDYLE is designed for single-use or multiple uses. As a temporary prosthesis, its intended use duration would depend on the clinical requirements and the treating professional's assessment.

• What regulatory approvals does the ADD-ON CONDYLE have?

  The ADD-ON CONDYLE received FDA 510(k) clearance (K002790) on August 6, 2001, as substantially equivalent to a predicate device. It is classified under product code NEI and manufactured by Walter Lorenz Surgical, Inc. in Jacksonville, Florida.