(360 days)
No
The 510(k) summary describes a physical medical device (orthodontic mini screws) and its material and dimensional properties. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The modifications described are purely mechanical (change in screw hole shape).
Yes
The device is intended to facilitate the orthodontic movement of teeth, which is a therapeutic intervention.
No
Explanation: The device, an orthodontic mini screw system, is intended to provide fixed anchorage for orthodontic appliances and facilitate tooth movement. It is a treatment device, not one that identifies or diagnoses a condition.
No
The device description clearly states the device is fabricated from stainless steel and titanium, indicating it is a physical hardware device (screws) and not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the screws are for providing fixed anchorage for orthodontic appliances to facilitate tooth movement. This is a mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the materials and physical characteristics of the screws, which are implanted devices.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OAT
Device Description
The Syntec Orthodontic Mini Screw Extended System is a modification of our own device Syntec Orthodontic Mini Screw (K090476). This minor change device system in its final finished form is identical to Syntec Orthodontic Mini Screw (K090476) in formulation, processing, and sterilization and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents). The modifications included in the subject submission are a change to the screw hole type, from the previously cleared circular design, to a rectangular shape.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical data and conclusions were not needed for these devices.
The Syntec Orthodontic Mini Screw Extended System was considered for conformance to dimensional and material mechanical property standards ASTM F138-13, F136-13 and ISO 5832-3. All items in the scope were in conformance with those standards. The Syntec Orthodontic Mini Screw Extended System has been subjected to safety, performance, and product validations prior to release.
Safety tests including biocompatibility (FDA recognized standard: ISO 10993-1) have been considered to ensure the devices comply with the applicable International and US regulations. Analysis of the worst case for performance testing, including fracture load, rotational fracture torque, and axial pull-out strength (FDA recognized standard: ASTM 543), showed that the testing of the predicate device was appropriate to be leveraged for the subject device. Therefore, these tests were not repeated in this submission.
The analysis information presented in this submission demonstrates that the subject device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
September 17, 2021
Syntec Scientific Corporation % Nicole Tseng Senior Regulatory Affairs Specialist Syntec Scientific Corporation - Taipei Office 3F., No.96, Sec. 3, Zhongxio East Road Da'An Dist., Tainei. R.O.C. 10652 TAIWAN
Re: K202790
Trade/Device Name: Syntec Orthodontic Mini Screw Extended System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: August 8, 2021 Received: August 18, 2021
Dear Nicole Tseng:
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. Although this letter refers to your product as a device, ple ase be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202790
Device Name
Syntec Orthodontic Mini Screw Extended System
Indications for Use (Describe)
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.
| 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) |
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Image /page/3/Picture/0 description: The image shows the logo for Syntec Scientific. The logo consists of a large orange circle to the left of a stylized blue letter 'S'. Below the shapes, the words 'SYNTEC SCIENTIFIC' are written in a simple sans-serif font, with 'SYNTEC' on the top line and 'SCIENTIFIC' on the bottom line.
SYNTEC SCIENTIFIC CORPORATION No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua Hsien, Taiwan R.O.C. TEL: +886-4-798-7099 E-mail: fda@eagleseye.com.tw Regulatory Affairs Specialist
This summary of 510(k) information is being submitted in accordance with the requirement of 21CFR 807.92.
510(k) K202790 Summary
| Submitted By: | Syntec Scientific Corporation |
|---|---|
| Address: | Syntec Scientific Corporation - Taipei Office |
| 3F., No.96, Sec. 3, Zhongxio East Road Da'An Dist. | |
| Taipei, Taiwan 10652 R.O.C. | |
| TEL: +886-4-798-7099 | |
| FAX: +886-4-798-7077 | |
| Date of Summary Prepared: | 2021-09-17 |
| Contact Person: | Nicole Tseng |
| Name of the Device: | Syntec Orthodontic Mini Screw Extended System |
| Trade or Proprietary Name: | Syntec Orthodontic Mini Screw Extended System |
| Common or Usual Name: | Ortho Anchor Screws |
| Classification Name: | Endosseous Dental Implant |
| Product Code: | OAT |
| Regulation Number: | 21 CFR 872.3640 |
| Class: | Class II |
| Predicate Device: | Syntec Orthodontic Mini Screw (K090476) |
| Reference Device: | Syntec Wetali Orthodontic Mini Screws (K142001) |
| Prior Submission: | None |
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Image /page/4/Picture/0 description: The image shows the logo for Syntec Scientific. The logo features a large orange circle overlapping a blue letter 'S'. Below the logo, the words 'SYNTEC SCIENTIFIC' are written in a simple, sans-serif font. The logo is clean and professional, suggesting a company involved in science or technology.
SYNTEC SCIENTIFIC CORPORATION
No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua Hsien, Taiwan R.O.C. TEL: +886-4-798-7099 E-mail: fda@eagleseye.com.tw Requlatory Affairs Specialist
1. Description of the Device
The Syntec Orthodontic Mini Screw Extended System is a modification of our own device Syntec Orthodontic Mini Screw (K090476).
2. Indications for Use
This Syntec Orthodontic Mini Screw Extended System is 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. Technological Characteristics Comparison to Previous Device
The Syntec Orthodontic Mini Screw Extended System is substantially equivalent (SE) to the predicate. The indications for use for this system are unchanged from the clearance of our predicate device, K090476. The screws are fabricated from stainless steel (SUS316L) per ISO 5832-1:2007/ASTM F138-13 and Titanium-6 Aluminum-4 Vanadium Eli (Extra Low Interstitial) Alloy per ISO 5832-3:1996/ASTM F136-13 as same as previous devices (K090476).
This minor change device system in its final finished form is identical to Syntec Orthodontic Mini Screw (K090476) in formulation, processing, and sterilization and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents). The modifications included in the subject submission are a change to the screw hole type, from the previously cleared circular design, to a rectangular shape. A brief summary of the technological characteristics of the minor change device in comparison to those of the predicate device as below table:
| Subject device | Predicate Device | |
|---|---|---|
| Device Name | Syntec Orthodontic Mini Screw | |
| Extended System | Syntec Orthodontic Mini Screw | |
| Applicant | Syntec Scientific Corporation | Syntec Scientific Corporation |
| 510(k) | K202790 | K090476 |
| Material Comparison | Surgical Stainless Steel (SUS316L) | |
| Surgical Titanium Alloy (Ti6AL-4V) | Surgical Stainless Steel (SUS316L) | |
| Surgical Titanium Alloy (Ti6AL-4V) | ||
| Screw Diameter | $ø$ 1.5 | $ø$ 1.5 |
ø1.5 Small Mushroom Style
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Image /page/5/Picture/0 description: The image shows the 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 simple sans-serif font. The logo appears to be a corporate logo for a scientific company.
SYNTEC SCIENTIFIC CORPORATION
No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua Hsien, Taiwan R.O.C. TEL: +886-4-798-7099 E-mail: fda@eagleseye.com.tw Regulatory Affairs Specialist
| Pitch | 0.68 mm | 0.68 mm |
|---|---|---|
| Thread Height | 0.25 mm | 0.25 mm |
| Length | 6~12 mm | 6~12 mm |
| Neck Length | 0.4 mm | 0.4 mm |
| Hole Shape Style | Rectangular/Circle | Circle |
ø2.0 Small Mushroom Style
| Screw Diameter | ø2.0 | ø2.0 |
|---|---|---|
| Pitch | 0.75 mm | 0.75 mm |
| Thread Height | 0.32 mm | 0.32 mm |
| Length | 6~12 mm | 6~12 mm |
| Neck Length | 0.4 mm | 0.4 mm |
| Hole Shape Style | Rectangular/Circle | Circle |
ø1.5 Large Mushroom Style
| Screw Diameter | ⌀1.5 | ⌀1.5 |
|---|---|---|
| Pitch | 0.68 mm | 0.68 mm |
| Thread Height | 0.25 mm | 0.25 mm |
| Length | 7~12 mm | 7~12 mm |
| Neck Length and | ||
| Hole Shape Style | 0.7 mm with Circle | |
| 0.8mm with Rectangular | ||
| 1.4 mm with Circle | 0.7 mm with Circle |
ø2.0 Large Mushroom Style
| Screw Diameter | ø2.0 | ø2.0 |
|---|---|---|
| Pitch | 0.75 mm | 0.75 mm |
| Thread Height | 0.35 mm | 0.35 mm |
| Length | 7~12 mm | 7~12 mm |
| Neck Length and | ||
| Hole Shape Style | 0.7 mm with Circle | |
| 0.8mm with Rectangular | 0.7 mm with Circle | |
| 1.2 mm with Circle |
Syntec, Taipei-Taiwan
K202790 - Page 3 of 4
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Image /page/6/Picture/0 description: The image shows the logo for Syntec Scientific. The logo features a large orange circle overlapping a blue letter 'S'. The text 'SYNTEC SCIENTIFIC' is written in black font below the graphic. There is a registered trademark symbol in the upper right corner of the logo.
SYNTEC SCIENTIFIC CORPORATION
No.2, Kung San Road, Chuan Shing Industrial Zone, Shen Kang, Chang Hua Hsien, Taiwan R.O.C. TEL: +886-4-798-7099 E-mail: fda@eagleseye.com.tw Requlatory Affairs Specialist
4. Summary of Performance Data (Nonclinical and/or Clinical) *Clinical Test
Clinical data and conclusions were not needed for these devices. *Non-Clinical Test
The Syntec Orthodontic Mini Screw Extended System was considered for conformance to dimensional and material mechanical property standards ASTM F138-13, F136-13 and ISO 5832-3. All items in the scope were in conformance with those standards. The Syntec Orthodontic Mini Screw Extended System has been subjected to safety, performance, and product validations prior to release.
Safety tests including biocompatibility (FDA recognized standard: ISO 10993-1) have been considered to ensure the devices comply with the applicable International and US regulations. Analysis of the worst case for performance testing, including fracture load, rotational fracture torque, and axial pull-out strength (FDA recognized standard: ASTM 543), showed that the testing of the predicate device was appropriate to be leveraged for the subject device. Therefore, these tests were not repeated in this submission.
*Conclusions
The analysis information presented in this submission demonstrates that the subject device is substantially equivalent to the predicate devices.
5. Substantial Equivalence
In conclusion, the Syntec Orthodontic Mini Screw Extended System has the same intended uses and indications and principles of operation to the predicate device. Performance testing showed that the device is not a new worst case in performance characteristics compared to the predicate. Thus, the Syntec Orthodontic Mini Screw Extended System is substantially equivalent in design, configuration, function, and indications for use to the previous own device.