(114 days)
Not Found
No
The 510(k) summary describes a physical orthodontic screw and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as "fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth," which is a therapeutic function.
No
Explanation: The device is an orthodontic screw, an implantable device used to facilitate tooth movement, and does not perform any diagnostic function.
No
The device description clearly states the device is a physical screw made of stainless steel and titanium alloy, intended for insertion into bone. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The provided description clearly states the device is a screw intended for fixed anchorage in bone to facilitate orthodontic tooth movement. It is a physical implant used directly on the patient's anatomy.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens.
The device described is a surgical implant used in orthodontics.
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
OAT
Device Description
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.
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
yz
510(k) SUMMARY
Submitter's name : Address :
す
510(K) SUMMARY
Syntec Scientific Corporation 2, Kung San Rd, Chuan Shing Industrial Zone, Shen Kang, Chang Hua, Taiwan. Telephone :886-4-7987099 Fax: 886-4-7987077
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 :
1
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 | |
| 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.
2
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 (800) 638-2041 or (240) 276-3150 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)