(136 days)
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No
The summary describes a mechanical orthodontic device and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device facilitates orthodontic movement of teeth by providing anchorage; it does not directly treat a disease or condition, but rather aids in a corrective dental procedure.
No
The device is described as providing a fixed anchorage point for orthodontic appliances to facilitate tooth movement, indicating it is a therapeutic or assistive device, not one used for diagnosis.
No
The device description explicitly states "Lin/Liou Orthodontic Mini Anchor System (LOMAS)" and describes it as providing a "fixed anchorage point" using "Screws," which are physical hardware components. There is no mention of software as the primary or sole component.
Based on the provided information, the Lin/Liou Orthodontic Mini Anchor System (LOMAS) is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to provide a fixed anchorage point for orthodontic appliances to facilitate tooth movement. This is a mechanical function performed in vivo (within the body), not in vitro (outside the body).
- Device Description: The description identifies it as an "Orthodontic Mini Anchor System," which aligns with a device used directly on a patient's teeth and bone.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
Therefore, the LOMAS is a medical device used for orthodontic treatment, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Lin/Liou Orthodontic Mini Anchor System (LOMAS) is 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 has been completed. Screws are intended for single use only
Product codes
DZE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/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" around the perimeter. Inside the circle is a stylized image of three overlapping shapes that resemble an eagle or bird in flight.
Public Health Service
JAN 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mondeal Medical Systems GmbH C/O Ms. Angelika Scherp Director, Regulatory Affairs Business Support International Amstel 320-1 1017AP Amsterdam The Netherlands
Re: K042345
Trade/Device Name: Lin/Liou Orthodontic Mini Anchor System (Lomas) Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: November 29, 2004 Received: November 30, 2004
Dear Ms. Scherp:
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.
1
Page 2 - Ms. Scherp
Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advised and 22 a determination that your device complies with other requirements modifine Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ouctial the Act's requirements, including, but not limited to: registration 1 ou intere comply wart 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 er read 001), eguality systems (QS) regulation (21 CFR Part 820); and if requirence as bet renis 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) Frider will and in Jo The FDA finding of substantial equivalence of your device to a premaince notification - 11 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), 11 you donto the Office of Compliance at (301) 594-0115. 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 may ovean 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/dsma/dsmamain.html
Sincerely yours,
Clats
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
2
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)
Indications for Use:
The Lin/Liou Orthodontic Mini Anchor System (LOMAS) is 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 has been completed. Screws are intended for single use only
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rapps
(Division Sign-Off) ് (Division of Anesthesiology, General Hospital, Infection Control Dental Dental Devices
510(k) Number:
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