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 Description

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.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Syntec Wetali Orthodontic Mini Screws." The core of the submission is to demonstrate substantial equivalence to a legally marketed predicate device, the "Syntec Orthodontic Mini Screws (K090476)."

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (typically from standards)	Reported Device Performance (from the study)
Met the standard of ASTM-F543 for pull-out strength.	Performance of the Syntec Wetali Orthodontic Mini Screws was comparable to the predicate device, meeting ASTM-F543.
Met the standard of ASTM-F543 for insertion torque.	Performance of the Syntec Wetali Orthodontic Mini Screws was comparable to the predicate device, meeting ASTM-F543.
Implicit Acceptance Criterion: Substantial equivalence in intended use, technological characteristics, and principles of operation to the predicate device.	Reported Performance: The Syntec Wetali Orthodontic Mini Screws has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. Minor technological differences raise no new issues of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The document states that "Both of comparative testing was done to our own predicate device," referring to the pull-out strength and insertion torque tests. However, it does not specify the sample size used for these tests.

Regarding data provenance:

Country of Origin: The company is Syntec Scientific Corporation, located in Taiwan (R.O.C.). It can be inferred that the testing was conducted by or on behalf of Syntec Scientific, likely in Taiwan or a region accessible to them.
Retrospective or Prospective: The text does not explicitly state whether the data was retrospective or prospective. Given that this is a premarket notification for a new version of a device, it is highly likely that the testing (e.g., mechanical tests like pull-out strength and insertion torque) was prospectively generated for the purpose of this submission. It's not clinical data, but rather mechanical testing data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable in this context. The "test set" for this submission consists of physical mechanical tests (pull-out strength and insertion torque) on the device, not clinical data requiring expert interpretation. The ground truth is established by the physical properties of the materials and the mechanical measurements, not by expert consensus in a medical diagnostic sense.

4. Adjudication Method for the Test Set

This information is not applicable. The "test set" involves objective mechanical measurements (pull-out strength and insertion torque) against a recognized standard (ASTM-F543), not subjective human assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic medical devices where expert readers evaluate images or data. The "Syntec Wetali Orthodontic Mini Screws" is a physical medical device (orthodontic mini screw) and its performance is evaluated through mechanical bench testing, not clinical imaging or diagnostic interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the device is not an algorithm or software requiring performance evaluation in a "standalone" or "human-in-the-loop" context. It is a physical medical device.

7. The Type of Ground Truth Used

The ground truth used here is based on objective mechanical measurements against a recognized industry standard. Specifically:

ASTM-F543 standard: This standard defines the methodologies and acceptable parameters for evaluating the mechanical properties of bone screws, including pull-out strength and insertion torque. The "ground truth" is that the device's performance metrics (e.g., the measured pull-out strength and insertion torque values) must conform to or be comparable to acceptable values defined by this standard and/or to the predicate device.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device and the presented evaluation. Training sets are typically used for machine learning algorithms or AI models. This submission focuses on physical device characteristics demonstrated through mechanical testing.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set."

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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 (+886-4-798-7099), and email address (fda@eagleseye.com.tw), 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 RoadChuan Shing Industrial Zone,Shen Kang, Chang Hua Hsien, Taiwan R.O.C.TEL: +886-4-798-7099FAX: +886-4-798-7077
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

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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: +886-4-798-7099 E-mail: fda@eagleseye.com.tw 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)andSurgical Titanium Alloy (Ti6AL-4V)	Surgical Stainless Steel (SUS316L)andSurgical 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 0.7mmdiameter hold.	The screws are with or without a0.65mm 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: +886-4-798-7099 E-mail: fda@eagleseye.com.tw 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.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.