(93 days)
Not Found
No
The summary describes a purely mechanical dental implant system with no mention of AI or ML components.
Yes
The device is described as "intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth." Facilitating the movement of teeth for orthodontic correction is a therapeutic function.
No
The device, a temporary anchorage system, is intended to provide a fixed anchorage point for orthodontic appliances to facilitate tooth movement. It is a tool for treatment, not for diagnosing conditions.
No
The device description explicitly states it consists of "sterile, single-use titanium screws," which are hardware components.
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 Vectors Temporary Anchorage System is a physical implantable device (a screw) that is inserted into bone to provide a mechanical anchor for orthodontic treatment. It does not perform any tests on bodily samples.
The description clearly states its purpose is to provide a "fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth." This is a mechanical function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Vectors Temporary Anchorage System is intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment. The screw is sterile and is intended for single use only.
Product codes
OAT
Device Description
The Vectors Temporary Anchorage System consists of sterile, single-use titanium screws that are available in 6, 8, 10, and 12mm lengths which are designed to aid in dental movement by providing a rigid skeletal fixation point. They are inserted into the bone and serve as a temporary anchor for various orthodontic tooth movements. The selfdrilling thread design allows for easy insertion and removal with the use of the system's driver. The product is sterilized using gamma radiation.
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)
Not Found
Reference Device(s)
Medicon eG. Aarhus Anchorage System, Dentaurum, Tomas Pin, Imtec Corporation, Ortho Implant, Mondeal Medical Systems, Lomas Quattro
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
Image /page/0/Picture/0 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are printed in a simple, sans-serif font. The logo is black and white.
AUG - 3 2006
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 100 Bayview Circle, Suite 6000 Newport Beach, California 92660 (949) 255-8766 - Phone (949) 255-8763 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: May 2006
Device Name:
- . Trade Name - Vectors Temporary Anchorage System
- Common Name Orthodontic Implant Screw .
- Classification Name Implant, Endosseous Dental, per 21 CFR § 872.3640 .
Devices for Which Substantial Equivalence is Claimed:
- Medicon eG. Aarhus Anchorage System .
- Dentaurum, Tomas Pin .
- Imtec Corporation, Ortho Implant ●
- Mondeal Medical Systems, Lomas Quattro .
Device Description:
The Vectors Temporary Anchorage System consists of sterile, single-use titanium screws that are available in 6, 8, 10, and 12mm lengths which are designed to aid in dental movement by providing a rigid skeletal fixation point. They are inserted into the bone and serve as a temporary anchor for various orthodontic tooth movements. The selfdrilling thread design allows for easy insertion and removal with the use of the system's driver. The product is sterilized using gamma radiation.
Intended Use of the Device:
The Vectors Temporary Anchorage System is intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment. The screw is sterile and is intended for single use only.
1
Substantial Equivalence:
The Vectors Temporary Anchorage System is substantially equivalent to other legally marketed devices in the United States. The Vectors Temporary Anchorage System is composed of the same material and is substantially equivalent in application and function to the Aarhus Anchorage System Screws, Tomas Pin, Ortho Implant and Lomas Quattro marketed by Medicon eG, Dentaurum, Imtec Corporation and Mondeal Medical Systems, respectively.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 2007
Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 100 Bayview Circle, Suite 6000 Newport Beach, California 92660-8915
Re: K061230
Trade/Device Name: Vectors Temporary Anchorage System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: OAT Dated: July 26, 2006 Received: July 27, 2006
Dear Ms. Boswell:
This letter corrects our substantially equivalent letter of August 3, 2006.
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 (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. Boswell
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 continue 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Chiu S. Lin, PhD
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, 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):
Device Name: Vectors Temporary Anchorage System
Indications for Use:
The Vectors Temporary Anchorage System is a threaded titanium dental implant screw intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment. The screw is sterile and is intended for single use only.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa Raser
Gion Sign-Off)
on of Anesthesiology, General Hospital,
mion Control, Dental Devices
Number: 1062530
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