IMTEC/TITANIUM MESH

K970841 · Imtec Corp. · JEY · Apr 30, 1997 · Dental

Device Facts

• Record ID: K970841
• Device Name: IMTEC/TITANIUM MESH
• Applicant: Imtec Corp.
• Product Code: JEY · Dental
• Decision Date: Apr 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• 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.

Indications for Use

Indicated for oral and maxillofacial surgery patients requiring stabilization and containment of bone graft material for the reconstruction of bony defects.

Regulatory Classification

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)
• 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)

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
[phone]

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.