SPEEDY ORTHODONTIC SCREW

K060500 · Dentium Co., Ltd. · DZE · Jun 16, 2006 · Dental

Device Facts

• Record ID: K060500
• Device Name: SPEEDY ORTHODONTIC SCREW
• Applicant: Dentium Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Jun 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Speedy Orthodontic Screw is intended for use as temporary anchor for orthodontic treatment.

Device Story

Speedy Orthodontic Screw is a temporary anchorage device for orthodontic tooth movement. Device consists of a titanium 6Al-4V alloy screw and head; implanted into maxilla or mandible by a clinician. Head facilitates connection of orthodontic wire. Device is supplied sterile for single use; removed upon completion of orthodontic treatment. Provides fixed anchorage to assist in tooth positioning.

Clinical Evidence

No clinical data. Safety and effectiveness supported by literature review and bench testing.

Technological Characteristics

Material: Titanium 6Al-4V alloy. Dimensions: 5.35-10.5mm total length. Design: Screw and head assembly for orthodontic wire connection. Sterilization: Supplied sterile. Single-use.

Indications for Use

Indicated for use as a temporary anchor for orthodontic treatment. Contraindicated in patients with osteoporosis, advanced diabetes, or metal allergies.

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

• Dual Top Anchor System Screws (K033767)

Submission Summary (Full Text)

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27-5 Leui-Dong, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, Korea 442-270 Tel [phone] Fax [phone]

Dentium

# 510(k) Summary

JUN 16 2006

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

Date: February 21, 2006

1. Company and Correspondent making the submission:

| Company | |
|---------|-----------------------------------------------------------------------|
| Name | Dentium Co., Ltd. |
| Address | 27-5 Leui-Dong, Yeongtong-Gu,<br>Suwon-Si, Gyeonggi-Do, Korea 442-270 |
| Phone | [phone] |
| Fax | [phone] |
| Contact | K. Y. Yoon |

## 2. Device:

Proprietary Name - Speedy Orthodontic Screw Common Name -- Small bone screw Classification Name - Endosseous dental implant

## 3. Predicate Device:

Dual Top Anchor System Screws, Jeil Medical Corporation, K033767

- 4. Classifications Names & Citations: 21CFR 872.3640, DZE, Endosseous dental implant, Class2
- 5. Description:

Speedy Orthodontic Screw is intended to provide a fixed anchorage for orthodontic movement of teeth. It is composed of screw and head; screw is implanted in the maxilla and/or mandible, and head is used for the connection of wire. It is from 5.35-10.5mm in total length and is made of Titanium 6Al-4V alloy. It is used temporarily and is removed after orthodontic treatment has been completed. It is supplied sterile and intended for single use only.

- 6. Indication for use:
The Speedy Orthodontic Screw is intended for use as temporary anchor for orthodontic treatment.

- 7. Contra-indications:
- 1) Osteoporosis

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27-5 Leui-Dong, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, Korea 442-270 | Demtiumm
Tel [phone] Fax [phone]

**Dentium**

- 2) Advanced diabetes
- 3) Metal allergies

#### 8. Review:

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

Speedy 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 Speedy Orthodontic Screw has been conducted. Appropriate safeguards have been incorporated in the design of Speedy 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 Dentium Co., Ltd. concludes that Speedy Orthodontic Screw is safe and effective and substantially equivalent to predicate devices as described herein.

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

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JUN 16 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dentium Company, Limited C/O Ms. Cathryn N. Cambria President Arkin Consulting Group 5536 Trowbridge Drive Dunwoody, Georgia 30338

Re: K060500

Trade/Device Name: Speedy Orthodontic Screw Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: June 12, 2006 Received: June 14, 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.

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 practice requirements as set forth in the quality systems (OS) 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 yours.

Clive
Shieh, Lin, 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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510(k) Number K K060500

Device Name: Speedy Orthodontic Screw

Indication for use: The Speedy Orthodontic Screw is intended for use as temporary anchor for orthodontic treatment.

Prescription Use______________________________________________________________________________________________________________________________________________________________ OR (Per 21CFR801 Subpart D)

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)

Sween Runne

Sign-Off)

of Anasthesiology, General Hospital,

ion Control, Dental Devices

Number. Kohoszcz