OSTEOMED ORTHODONTIC SCREW SYSTEM

K031936 · Osteomed LP · DZE · Jan 7, 2004 · Dental

Device Facts

• Record ID: K031936
• Device Name: OSTEOMED ORTHODONTIC SCREW SYSTEM
• Applicant: Osteomed LP
• Product Code: DZE · Dental
• Decision Date: Jan 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.

Device Story

System provides fixed anchorage for orthodontic appliances to facilitate tooth movement. Comprised of titanium alloy screws (1.2mm–2.0mm diameter; 4.0mm–8.0mm thread length), pilot drills, and screwdrivers. Used temporarily in clinical settings; removed upon completion of orthodontic treatment. Single-use device.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to predicate devices.

Technological Characteristics

Titanium alloy screws; diameters 1.2mm–2.0mm; thread lengths 4.0mm–8.0mm. System includes pilot drills and screwdrivers. Mechanical fixation principle.

Indications for Use

Indicated for patients requiring fixed anchorage for orthodontic tooth movement; intended for temporary use and removal post-treatment.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• Straumann Ortho Implant (K982509)
• Nobel Biocare Inplant Orthodontic Anchor System (K000643)

Submission Summary (Full Text)

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JAN - 7 2004

K031936

## 510(k) Summary

Device Proprietary Name:

Device Common Name:

Classification Name:

Name of Submitter:

OsteoMed Orthodontic Screw System

Bone Screw

DZE, Implant, Endosseous

OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: [phone] Fax: [phone]

Contact Person:

Dawn T. Holdeman

May 23, 2003

Date Prepared:

Summary:

This submission describes the OsteoMed Orthodontic Screw System intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.

The OsteoMed Ofthodontic Screw System is comprised of screws in diameters of 1.2mm to 2.0mm in thread lengths of 4.0mm to 8.0mm. The screws are made from titanium allov. Pilot Drills and screwdrivers will also be a part of the system.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Straumann Ortho Implant (K982509) and the Nobel Biocare Inplant Orthodontic Anchor System (K000643).

Due to the similarity of materials and design to the predicate device, OsteoMed believes that the OsteoMed Orthodontic Screw System does not raise any new safety or effectiveness issues.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2004

Ms. Dawn T. Holdeman Regulatory Affairs and Document Control OsteoMcd L.P. 3885 Arapaho Road Addison, Texas 75001

Re: K031936

Trade/Device Name: Osteomed Orthodontic Screw System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: October 9, 2003 Received: October 10, 2003

Dear Ms. Holdeman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale commerce prior to tray been reclassified in accordance with the provisions of Amendinena, I. 1. 10 ab road Cosmetic Act (Act) that do not require approval of a premarket the I cacial I ood, 171ag, dAD Obbu may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls process for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 vir y, it may be bacyco in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be roundsh further announcements concerning your device in the Ecdgral Register.

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Page 2 – Ms. Holdeman

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements mount that 1 Drimal statutes and regulations administered by other Federal agencies. or the Act of ally I outhal the Act's requirements, including, but not limited to: registration r our must comply with a 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part of the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) Premarket white wification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n you deathe specifical at [phone]. Also, please note the regulation entitled. "Misbranding by reference to promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu-Ling Lu, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## OsteoMed "Indications for Use" Submission

510(k) Number:

KO31936

| Device Name: | OsteoMed Orthodontic Screw System |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | Indicated to provide a fixed anchorage point for attachment of<br>orthodontic appliances to facilitate the orthodontic movement of<br>teeth. It is used temporarily and is removed after orthodontic<br>treatment has been completed. Screws are intended for single<br>use only. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 810.109) Over-The Counter-Use (Optical Format 1-)

Susan Runn

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: *k031931*