(57 days)
Tomas-pins are temporary, enossal anchorage point for attachment of orthodontic appliances.
To provide a fixed anchorage point for attachments of orthodontic appliances.
tomas-pin micro screws (orthodontic micro implant) are anchorage elements made of grade 5 titanium (3.7165), according to ASTM (American Society for Testing and Materials). They are inserted into the bone and serve as a temporary anchor for various orthodontic tooth movements. The tomaspin is constructed as follows: The screw features hex type slots. Rectangular wires are inserted to accommodate orthodontic elements, such as arches, elastic bands and brackets. Preferably, the wire should be fixed on the tomas-pin with light cured adhesive should completely/fully enclose the wire and retention head. The retention channel below the slots serves to securely anchor the adhesive to the tomas-on. This also protects the soft tissue (cheek, lips, tongue) against irritation that could result from the screw head.
The thread of the tomas-pin SD is self-drilling. The tomas-pin SD is inserted and screwed into the bone by either manual or mechanical method.
The shoulder connection between the thread and soft tissue sleeve serves as a stop to prevent the tomas-pin from sinking into the soft tissue. The soft tissue sleeve between the thread and retention head helps to prevent irritation between the gingiva and the tomas-pin, therefore.
The provided document is a 510(k) premarket notification summary for the Dentaurum tomas-pin (Temporary Orthodontic Micro Anchorage System). This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with detailed acceptance criteria and supporting data for a new device.
Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a device performance study.
Instead, it relies on a comparison of the tomas-pin device to predicate devices based on:
- Intended Use: The tomas-pin has the same intended use as the predicate devices: "To provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed."
- Material: The tomas-pin is made of Titanium Grade 5 (ASTM), which is similar to the Titanium and Titanium Alloy (ASTM F 136-98) used in the predicate devices.
- Design and Characteristics: The submission states that the tomas-pin has similar dimensions and characteristics to the predicate devices.
- Potential Adverse Effects: These are identified as identical to those of the predicate devices.
The conclusion drawn is that the tomas-pin is "substantially equivalent in design, material, intended use and function" to the listed predicate devices. There is no performance study described in this document to assess specific acceptance criteria for a new device's efficacy or accuracy.
§ 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.