SUPER ORTHODONTIC SCREW

K062156 · Osstem Implant Co., Ltd. · DZE · Oct 20, 2006 · Dental

Device Facts

• Record ID: K062156
• Device Name: SUPER ORTHODONTIC SCREW
• Applicant: Osstem Implant Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Oct 20, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Super Orthodontic Screw is indicated for use as 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

Super Orthodontic Screw is a titanium alloy dental implant used as a temporary fixed anchorage point for orthodontic appliances. The device consists of a screw (1.6-1.8 mm diameter; 6-12 mm length) with a TiN-coated head featuring a wire-attachment hole. It is implanted by a clinician to facilitate tooth movement and is removed upon treatment completion. The device is supplied non-sterile and requires steam sterilization before use. It provides a stable anchor for orthodontic wires, aiding in the correction of malocclusions.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, performance validation, and a review of literature regarding the safety and biocompatibility of the device materials and design.

Technological Characteristics

Material: Titanium 6Al-4V alloy (ASTM F 136-98). Head coating: Titanium Nitride (TiN). Dimensions: 1.6-1.8 mm diameter; 6, 8, 10, 12 mm lengths. Sterilization: Steam heat. Design: Non-treated screw surface with wire-attachment hole in head.

Indications for Use

Indicated for patients requiring temporary fixed anchorage for orthodontic tooth movement. Contraindicated in patients with osteoporosis, advanced diabetes, or metal allergy.

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

• Osteomed Orthodontic Screw System (K031936)
• Dual Top Anchor System Screws (K033767)

Submission Summary (Full Text)

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K062156

Image /page/0/Picture/1 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The address is #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea. The phone number is [phone], the fax number is [phone], and the website is www.osstem.com.

P 1 2

001 2006

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: July 25, 2006

1. Company and Correspondent making the submission:

| | Company |
|---------|---------------------------------------------------|
| Name | Osstem Implant Co., Ltd. |
| Address | #507-8 Geoje3-Dong Yeonje-GuBusan, 611-804, Korea |
| Phone | [phone] |
| Fax | [phone] |
| Contact | Sung Ryul, Kim |

#### 2. Device:

Proprietary Name - Super Orthodontic Screw Common Name - Dental Implant Classification Name - Endosseous dental implant

### 3. Predicate Device:

Osteomed Orthodontic Screw System, Osteomed L.P., K031936 Dual Top Anchor System Screws, Jeil Medical Corporation, K033767

- 4. Classifications Names & Citations:
21CFR 872.3640, DZE, Endosseous dental implant, ClasslI

### 5. Description:

The Super Orthodontic Screw is a dental implant system made of titanium metal intended to be used as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is 1.6 and 1.8 mm in screw diameter and 6, 8, 10, 12mm in length. It is made of Titanium 6AI-4V alloy(ASTM F 136-98). The surface of the screw is non-treated and that of head is TiN coated. There is a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. It is supplied non-sterile and must be sterilized prior to use by Steam heat sterilization.

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K062156

# TEM Implant Co., Ltd.

07-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Phone: [phone] Fax: [phone] www.osstem.com

- Indication for use: 6.
Super Orthodontic Screw is indicated for use as 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.

- 7. Contra-indications: Osteoporosis Advanced diabetes Metal allergy
- 8. Review:

Super Orthodontic Screw has the same device characteristics as the predicate device. Material, design and use concept is similar.

Super Orthodontic Screw has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations.

An extensive review of literature pertaining to the safety and biocompatibility of Super Orthodontic Screw has been conducted. Appropriate safeguards have been incorporated in the design of Super Orthodontic Screw.

- 9. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Osstem Implant Co., Ltd. concludes that Super Orthodontic Screw is safe and effective and substantially equivalent to predicate devices as described herein.

- Osstem Implant Co., Ltd. will update and include in this summary any other 10. information deemed reasonably necessary by the FDA.
- END

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is depicted in a simple, bold design, and the text is in a clear, sans-serif font. The overall design is clean and professional, reflecting the department's role in public health and human services.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Osstem Implant Company Limited C/O Ms. Cathryn Cambria Consultant Cambria Regulatory Consulting, Incorporated 5536 Trowbridge Drive Dunwoody, Georgia 30338

Re: K062156

Trade/Device Name: Super Orthodontic Screw Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 2, 2006 Received: October 5, 2006

Dear Ms. Cambria:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

OCT 2 0 2006

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 your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Cambria

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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing rogatice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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 notification. 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division 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/industry/support/index.html.

Sincerely vours.

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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K062156

510(k) Submission – Super Super Orthodontic Screw

510(k) Number K

Device Name: Super Orthodontic Screw

Indication for use: Super Orthodontic Screw is indicated for use as 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.

Prescription Use
(Per 21CFR801 Subpart D) OR

Over-The-Counter Use _ (Per 21CFR807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kei Mulvey for MSR

esthesiology. General Hospital,

550(k) Number: Ko 62156