SYNTEC ORTHODONTIC MINI SCREW

K090476 · Syntec Scientific Corp. · OAT · Jun 18, 2009 · Dental

Device Facts

• Record ID: K090476
• Device Name: SYNTEC ORTHODONTIC MINI SCREW
• Applicant: Syntec Scientific Corp.
• Product Code: OAT · Dental
• Decision Date: Jun 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only.

Device Story

Syntec orthodontic mini screws provide temporary skeletal anchorage for orthodontic appliances. Screws feature self-tapping and self-drilling flutes for manual insertion into maxillary or mandibular bone by orthodontists. Available in diameters 1.3mm–2.0mm and lengths 5mm–17mm; optional 0.65mm hole in head for attachment. Device remains in situ during treatment to facilitate tooth movement; removed upon completion. Benefits include stable anchorage for complex orthodontic mechanics.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and intended use comparisons to the predicate device.

Technological Characteristics

Materials: SUS316L stainless steel (ISO 5832-1) and Ti-6AL-4V titanium alloy (ISO 5832-3). Design: Self-tapping/self-drilling flutes; 1.3-2.0mm diameter; 5-17mm length. Sterilization: Non-sterile; steam autoclave required before use.

Indications for Use

Indicated for patients requiring fixed anchorage to facilitate orthodontic tooth movement. Used temporarily in maxillary and mandibular bone; intended for removal post-treatment. Single use only.

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

• Leone Orthodontic Mimi Implant (K071490)

Submission Summary (Full Text)

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# 510(k) SUMMARY

Submitter's name : Address :

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K690476

# 510(K) SUMMARY

Syntec Scientific Corporation 2, Kung San Rd, Chuan Shing Industrial Zone, Shen Kang, Chang Hua, Taiwan. Telephone :[phone] Fax: [phone]

JUN 18 2009

Date the summary was prepared : April 25, 2008

| Name of the device : | Syntec orthodontic mini screws |
|-----------------------------|-----------------------------------|
| Trade or proprietary name : | Syntec orthodontic mini screws |
| Common or usual name : | Ortho Anchor Screws |
| Classification name : | Implants, Endosseous, Orthodontic |
| Prode Code : | OAT |
| Regulation No. : | 872.3640 |
| Class : | II |

## 1. Description of the Device:

The screws are manufactured from commercially SUS316L ( stainless steel ) and Ti-6AL-4V ( titanium alloy ) . The screws are available with thread diameter are from 1.3mm to 2.0 mm, and total lengths from 5mm to 17mm. There is a pair of self-tapping flutes and self-drilling flutes for easy insertion and removal. The design of smooth curve surface of screw head is comfortable to patients, and the screws with or without a 0.65mm diameter hole can supply different orthodontic methods for orthodontists.

## 2. Indications for Use:

The screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only.

3.Substantial Equivalence :

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K090476

The Syntec orthodontic mini screws have same intended use as the Leone Orthodontic Mimi Implant from Leone SpA, 50 Via P. a Quaracchi Sesto, Fiorentino, IT-500 19, cleared 510 ( k ) no. K071490, and have equivalent performance characteristics.

| Device Name | Syntec orthodontic mini screws | Leone orthodontic mini implant |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | OAT | OAT |
| Regulation no. | 872.3640 | 872.3640 |
| Applicant | Syntec Scientific Corporation (Taiwan) | Leone SpA ( Italy ) |
| 510 (k) | This Submission | K071490 |
| Intended use | The screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only. | Provide a fixed anchorage for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily in the maxillary and mandibular bone and must be removed after orthodontic treatment has been completed. |
| Material | Surgical stainless steel ISO 5832-1<br>Surgical titanium alloy ISO 5832-3 | Surgical stainless steel ISO 5832-1 |
| Sterility | Non-sterile. Steam sterilize before use. | Non-sterile. It is recommended to sterilize with steam autoclave before use. |

## 4.Conclusion:

1 - 1

.***

The Syntec orthodontic mini screws raises no new issues of safety or effectiveness. The Syntec orthodontic mini screws does not additional concerns regarding safety and may therefore be considered substantially equivalent to the predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

#### Public Health Service

# .HIN 18 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Susan Cheng Syntec Scientific Corporation 3F1. 96 Chung Hsiao E. Road Section 3 Taipei CHINA (TAIWAN) 106

Re: K090476

Trade/Device Name: Syntec Orthodontic Mini Screws Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: June 11, 2009 Received: June 16, 2009

Dear Ms. Cheng:

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 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. Cheng

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/Centers Offices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance.and Biometrics/Division of Postmarket Surveillance.

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,

Susan Runoe

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# INDICATION FOR USE

# Indications for Use

## 510(k) Number (if known): Device Name: Syntec orthodontic mini screws Indications for Use: .

The screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only.

Kein Huluy for M.J.R
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K090476

Prescription Use AND/OR Over-The-Counter Use ( Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)