(46 days)
Not Found
No
The device description and intended use focus on the mechanical properties and function of a physical screw, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as facilitating the orthodontic movement of teeth, which is a therapeutic function.
No
The device is used to anchor orthodontic appliances for tooth movement, not to diagnose a condition or disease.
No
The device description clearly states it is a physical screw made of titanium alloy, intended for surgical implantation. It 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Ortho Anchor Screws are physical implants used to provide anchorage for orthodontic appliances. They are used in vivo (within the body) to facilitate tooth movement.
- Intended Use: The intended use clearly states they are for "providing fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth." This is a mechanical function within the body, not a diagnostic test performed on a sample.
The description and intended use clearly indicate this is a surgical/implantable device used for a therapeutic purpose (orthodontic treatment), not a diagnostic test.
N/A
Intended Use / Indications for Use
The Ortho Anchor 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 MIS Ortho Anchor Screws are self-tapping screws that are used as fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth.
The screw is manufactured as one piece screw made of medical grade 5 Titanium alloy complying with the standard ASTM F136-02. The upper head of the screw has a cross-hole through which a wire can pass to fix the mandible and maxilla in the orthodontic procedure. The screw head is special designed to assist the use of orthodontic appliances.
The Ortho Anchor Screws are provided in several lengths ranging between 5-10mm and diameters of 1.4mm, 1.6mm and 2mm. The screws are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are supplied sterile.
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
K073461
MIE
510(k) Summary:
Ortho Anchor Screws
Company Name -
MIS - Implant Technologies Ltd. POB 110 Shlomi Industrial Zone Shlomi 22832 ISRAEL Telephone: +972-4-980-9966 Fax: +972-4-980-9944
JAN 25 2006
Establishment Registration Number: 3004203816
Contact Name: Iman Khorshid Quality Manager Telephone: +972-4-980-9966 Fax: +972-4-980-9944 E-mail: iman@mis-implants.com
US Agent: Motti Weisman - VP Marketing MIS Implants Technologies Inc. 278 Broadway Elmwood Park, NJ 07407 Phone: (201) 797-9144 Fax: (201) 797-9145 E-mail: mis.service@verizon.net
Date prepared: November 9, 2007
Trade Name: Ortho Anchor Screws
Classification name: Implants, Endosseous, Orthodontic
Common/usual name: Ortho Anchor Screws
Product Code: OAT
Regulation No.: 872.3640
Class: II
Panel identification: Dental Devices Panel 5-2
1
Predicate Device:
Dual Top Anchor System Screws from Jeil Medical Cooperation, P.O. Box 7007, Deerfiled, IL 60015, cleared under 510(k) no. K033767
Description of the device:
The MIS Ortho Anchor Screws are self-tapping screws that are used as fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth.
The screw is manufactured as one piece screw made of medical grade 5 Titanium alloy complying with the standard ASTM F136-02. The upper head of the screw has a cross-hole through which a wire can pass to fix the mandible and maxilla in the orthodontic procedure. The screw head is special designed to assist the use of orthodontic appliances.
The Ortho Anchor Screws are provided in several lengths ranging between 5-10mm and diameters of 1.4mm, 1.6mm and 2mm. The screws are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are supplied sterile.
Indications for Use:
The Ortho Anchor 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.
Substantial Equivalence:
The MIS Ortho Anchor Screws have the same intended use as the Dual Top Anchor System Screws from Jeil Medical Cooperation, P.O. Box 7007, Deerfiled, IL 60015, cleared under 510(k) no. K033767, and have equivalent performance characteristics. Both products are manufactured from the same Titanium allov. All other technological characteristics are similar and show equivalent performance capabilities. The Ortho Anchor Screws are therefore substantially equivalent to the predicate devices.
Conclusion -
The evaluation of the Ortho Anchor Screws does not raise any additional concerns regarding safety and effectivity and mav therefore be considered substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health and Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three human profiles facing to the right. The symbol is composed of three curved lines that are connected at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 25 2008
Ms. Iman Khorshid Quality Manager M.I.S. - Implants Technologies Limited P.O.B. 110 Shlomi Industrial Zone Shlomi, ISRAEL 22832
Re: K073461
Trade/Device Name: Ortho Anchor Screws Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: November 9, 2007 Received: December 10, 2007
Dear Ms. Iman Khorshid:
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 such 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.
3
Page 2- Ms. Iman Khorshid
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
| 510(k) Number (if known): | K073461 |
|---|---|
| Device Name: | Ortho Anchor Screws |
| Indications for Use: | The Ortho Anchor 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. |
|---|---|
| ---------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Prescription Use OR X (Part 21 CFR 801 Subpart D)
Over the Counter Use (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)
Susan Runne
1991 - 19 ് പ്രവാലയിലെ പ്രാപ്പ് 21, 11 11 1042 3