Search Results

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.

Ask a specific question about this device