SYNTEC WETALI ORTHODONTIC MINI SCREWS

K142001 · Syntec Scientific Corporation - Taipei Office · OAT · Mar 18, 2015 · Dental

Device Facts

• Record ID: K142001
• Device Name: SYNTEC WETALI ORTHODONTIC MINI SCREWS
• Applicant: Syntec Scientific Corporation - Taipei Office
• Product Code: OAT · Dental
• Decision Date: Mar 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Syntec Wetali Orthodontic Mini Screws serve as temporary fixed anchorage for orthodontic appliances. Device consists of surgical stainless steel (SUS316L) or titanium alloy (Ti6AL-4V) screws; available in various thread diameters (1.4-2.0mm) and lengths (6.0-12.0mm). Features self-drilling design for insertion/removal; smooth head surface for patient comfort; optional 0.7mm diameter hole for attachment. Used by orthodontists in clinical settings to provide stable anchorage points, facilitating controlled tooth movement. Removed upon completion of orthodontic treatment. Benefits include improved anchorage stability and ease of insertion compared to previous designs.

Clinical Evidence

Bench testing only. Performance evaluation included pull-out strength and insertion torque testing conducted in accordance with ASTM-F543 standards to demonstrate equivalence to the predicate device.

Technological Characteristics

Materials: Surgical Stainless Steel (SUS316L) and Titanium Alloy (Ti6AL-4V). Dimensions: Thread diameter 1.4-2.0mm; length 6.0-12.0mm. Design: Self-drilling, smooth-curved head, optional 0.7mm diameter hole. Mechanical principle: Endosseous screw fixation. No software or energy source.

Indications for Use

Indicated for patients requiring fixed anchorage for orthodontic appliance attachment to facilitate tooth movement. Used temporarily and removed 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

• Syntec Orthodontic Mini Screws (K090476)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 18, 2015

Syntec Scientific Corporation c/o Mr. Kavin Chu Syntec Scientific Corporation - Taipei Office 3F., No.96, Sec. 3, Zhongxio East Road Da'An Dist. Taipei, TAIWAN 10652

Re: K142001

Trade/Device Name: Syntec Wetali Orthodontic Mini Screws Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: February 3, 2015 Received: February 12, 2015

Dear Mr. Chu:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 - Mr. Kavin Chu

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K142001

Device Name SYNTEC WETALI ORTHODONTIC MINI SCREWS

Indications for Use (Describe) THE SCREWS ARE INDICATED FOR USE AS A FIXED ANCHORAGE FOR ATTACHMENT OF ORTHODONTIC APPLIANCES TO FACILITATE THE ORTHODONTIC MOVEMENT OF TEETH. THEY ARE USED TEMPORARILY AND ARE REMOVED AFTER ORTHODONTIC TREATMENT HAS BEEN COMPLETED. THEY ARE INTENDED FOR SINGLE USE ONLY.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo and contact information for Syntec Scientific Corporation. The logo features the letters "OS" in blue and orange. The text includes the company name, address (No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua Hsien, Taiwan R.O.C.), phone number ([phone]), and email address ([e-mail]), along with the title Regulatory Affairs Manager.

## This summary of 510(k) information is being submitted in accordance with the requirement of SMDA 1990 and 21CFR 807.92.

# 510(k) SUMMARY

| Submitted By: | Syntec Scientific Corporation |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | No.2, Kung San Road<br>Chuan Shing Industrial Zone,<br>Shen Kang, Chang Hua Hsien, Taiwan R.O.C.<br>TEL: [phone]<br>FAX: [phone] |
| Date Summary Prepared: | June 25, 2014 |
| Contact person: | Kavin Chu |
| Name of the device: | Syntec Wetali Orthodontic Mini Screws |
| Trade or proprietary name: | Syntec Wetali Orthodontic Mini Screws |
| Common or usual name: | Ortho Anchor Screws |
| Classification name: | Endosseous Dental Implants |
| Produce code: | OAT |
| Regulation number: | 872.3640 |
| Class: | Class II |
| Predicate devices: | Syntec Orthodontic Mini Screws (K090476) |

### 1. Description of the Device

The screws are manufactured from commercially SUS316L (stainless steel) and Ti6AL-4V (Titanium alloy). The screws are available with thread diameter are from 1.4mm to 2.0 mm, and total thread lengths from 6.0mm to 12.0mm. The minor technological modification for Syntec Wetali Orthodontic Mini Screws is re-designed self-drilling angle for more easily insertion and removal. The design of smooth curve surface of screw head is comfortable to patient and the screws with or without a 0.7mm diameter hole can supply different orthodontic methods for orthodontists.

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Image /page/4/Picture/0 description: The image shows the logo for Syntec Scientific. The logo features a red circle overlapping a blue stylized letter 'S'. Below the graphic is the text 'SYNTEC SCIENTIFIC' in a simple, sans-serif font. The logo appears to be a corporate or brand identity mark.

SYNTEC SCIENTIFIC CORPORATION No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kanq Chang Hua Hsien, Taiwan R.O.C. TEL: [phone] E-mail: [e-mail] Regulatory Affairs Manager

## 2. Intended Use

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

### 3. Technological Characteristics, comparison to predicate device

Technically, the Syntec Wetali Orthodontic Mini Screws is identical to the Syntec Orthodontic Mini Screws cleared for market in 510(k) K090476 and essentially equivalent to the other predicate. The indications for use for the Syntec Wetali Orthodontic Mini Screws are patterned after the predicate devices and supported by an extensive collection of literature references.

| | Subject device | Predicate Device |
|-------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Device Name | Syntec Wetali Orthodontic Mini Screws | Syntec Orthodontic Mini Screws |
| Applicant | Syntec Scientific Corporation | Syntec Scientific Corporation |
| 510(k) | K142001 | K090476 |
| Material | Surgical Stainless Steel (SUS316L)<br>and<br>Surgical Titanium Alloy (Ti6AL-4V) | Surgical Stainless Steel (SUS316L)<br>and<br>Surgical Titanium Alloy (Ti6AL-4V) |
| Thread Diameter | From 1.4mm to 2.0mm | From 1.3mm to 2.0mm |
| Thread Length | From 6.0mm to 12.0mm | From 5.0mm to 12.0mm |
| Screw Head Design | The screws are with or without a 0.7mm<br>diameter hold. | The screws are with or without a<br>0.65mm diameter hold. |

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Image /page/5/Picture/0 description: The image shows a logo for Syntec Scientific. The logo features a large orange circle overlapping a blue letter 'S'. Below the graphic is the text 'SYNTEC SCIENTIFIC' in a serif font. The logo appears to be a stylized representation of the company's name.

SYNTEC SCIENTIFIC CORPORATION No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kanq Chang Hua Hsien, Taiwan R.O.C. TEL: [phone] E-mail: [e-mail] Requlatory Affairs Manager

## 4. Performance Data (Nonclinical Testing)

The procedure of evaluating the pull out strength and insertion torque was according to the standard of ASTM-F543. Both of comparative testing was done to our own predicate device to demonstrate substantial equivalence.

### 5. Substantial Equivalence

The Syntec Wetali Orthodontic Mini Screws is as safe and effective as Syntec Orthodontic Mini Screws (K090476). The Syntec Wetali Orthodontic Mini Screws has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Syntec Wetali Orthodontic Mini Screws and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Syntec Wetali Orthodontic Mini Screws is as safe and effective as Syntec Orthodontic Mini Screws (K090476). Thus, the Syntec Wetali Orthodontic Mini Screws is substantially equivalent and presents no new concerns about safety and effectiveness.