← Product Code [JEY](/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY) · K970841

# IMTEC/TITANIUM MESH (K970841)

_Imtec Corp. · JEY · Apr 30, 1997 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K970841

## Device Facts

- **Applicant:** Imtec Corp.
- **Product Code:** [JEY](/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY.md)
- **Decision Date:** Apr 30, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4760
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** Therapeutic

## Intended Use

The IMTEC/TitaniumMesh is intended for use in oral and maxillofacial surgery for the stabilization and containment of bone graft material in the reconstruction of bony defects.

## Device Story

Device consists of laser-cut, precision-expanded, flattened, and annealed titanium mesh; used in oral and maxillofacial surgery. Function: stabilization and containment of bone graft material during reconstruction of bony defects. Operation: surgeon shapes and secures mesh over graft site to maintain graft volume and position. Benefit: facilitates bone regeneration by preventing soft tissue ingrowth and maintaining graft integrity. Marketed sterile.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Material: Titanium; precision expanded, flattened, and annealed. Form factor: Laser-cut mesh with specific size and pore dimensions. Sterilization: Provided sterile.

## Regulatory Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

## Predicate Devices

- Leibinger, Micro-Titanium Augmentation Mesh (M-TAM™) ([K862532](/device/K862532.md))
- Osteomed, Osteomed MSS (Ti Ridge Augmentation Material) ([K963394](/device/K963394.md))
- Walter Lorenz Surgical, Inc., Ti Mini Bone Plate and Screws ([K862482](/device/K862482.md))
- TiMesh Inc., Reconstructive Surgery System ([K923491](/device/K923491.md))

## Submission Summary (Full Text)

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K970841
APR 30 1997

510 (k) Summary of Safety and Effectiveness

## SUBMITTED BY:

M. K. Patterson, Jr. PhD
Sr Vice President
Regulatory Affairs
IMTEC Corporation
2401 North Commerce
Ardmore, Oklahoma 73401
(405) 223-4456

F.D.A Registration Number: 1645158
Owner / Operator Number: 9003407

Date Submitted: March 5,1997

## CLASSIFICATION/COMMON OR USUAL NAME/ DEVICE NAME:

Classification Name: Precision expanded Titanium foil (CFR 878.3300)
Common/ Usual Name: Titanium Mesh.
Proprietary Name: IMTEC/ TitaniumMesh

## PREDICATE DEVICE:

Leibinger, Micro-Titanium Augmentation Mesh ( M-TAM™) K 862532
Osteomed, , Osteomed MSS (Ti Ridge Augmentation Material) K963394
Walter Lorenz Surgical, Inc., Ti Mini Bone Plate and Screws, K862482
TiMesh Inc., Reconstructive Surgery System,K923491

## DEVICE DESCRIPTION:

The IMTEC/TitaniumMesh consists of a laser cut segment of precision expanded, flattened and annealed Titanium Mesh of a specific size dimension and pore dimension. The device will be marketed sterile.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K970841](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/JEY/K970841)

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