(116 days)
This device is intended 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. Screws are intended for single use only on adults over the age of 12.
This device is an endosseous dental implant consisting of the major component, of root-form, screw type, and the accessories, designed to facilitate placing and using the implant in orthodontic procedures. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally. The smoothly curved head has a groove in the middle for the attachment of elastics, chains, or coil springs commonly used in orthodontics. The head (groove) has a aperture where a wire or auxiliary can be attached. The rounded head of the implant has an internal hexagon for insertion of the screw driver. The MAS implant is made from Group V titanium.
This 510(k) summary describes a dental implant device called the Miniscrews Anchoring System (MASᵀᴹ System). However, it does not contain details about acceptance criteria or a study proving the device meets specific performance metrics.
The document focuses on establishing substantial equivalence to existing predicate devices based on:
- Intended Use: Providing a fixed anchorage point for orthodontic appliances.
- Technological Characteristics: Screw-type endosseous dental implants made of Grade V titanium with similar design concepts (e.g., rounded head with a groove for attachments, self-tapping, roughened screw area, smoothly machined transmucosal neck).
- Materials: Group V titanium, which is a well-established material in the industry.
Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
- If a standalone performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
This submission is a traditional 510(k) that relies on demonstrating substantial equivalence to already cleared devices, rather than presenting novel performance data against specific acceptance criteria. The FDA's letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing its market entry based on this comparison.
§ 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.