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Intended to be placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

Examples:

Support andhors for temporary restorations during the healing and osseointegration process of permanent implants.

Immediate loading temporary abutments for repairing failing tooth and implant suported restorations.

Transitional supports for immediate replacement of missing teeth.

Provide assistance in case planning, implant position alignments, and interim anchor foundations.

The Dentatus Mini Transitional Implants (MTTM) are titanium or titanium-alloy threaded posts, 1.8 mm to 2.5 mm in diameter and from 14 to 22 mm. in length. There are variations; they are threaded at the bottom-self-tapping, and the "head" is of slightly varying shapes.

The provided text is a 510(k) summary for the Dentatus MTI Modular Transitional Implants. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

This type of submission does not typically include a detailed study with acceptance criteria and device performance results as it focuses on demonstrating substantial equivalence, not conducting new clinical trials for effectiveness against specific performance metrics.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, along with specific details about sample size, ground truth, expert qualifications, adjudication, MRMC studies, and training set information, is not present in the provided document.

Instead, the document focuses on:

• Substantial Equivalence: Comparing the device to pre-amendment devices and several currently marketed devices (e.g., Sendax MDI implant K-972351, Bofors Nobelpharma K-820013, etc.) based on shape, form, composition, usability, and materials.
• Literature Review: Summarizing existing literature on endosseous implants and their transitional use to support the safety and effectiveness of the underlying technology and materials (titanium and titanium alloy). This literature review mentions:
  • Possible adverse effects listed by the US classification panel.
  • A quote from Matukas stating "Little or no hard data could be found on the medical risks associated with [dental] implants."
  • A review of the literature by Smith and Zarb proposing criteria for implant success (but these criteria are not detailed or applied to the Dentatus device in this summary).
  • The "Proceedings of the Consensus Development Conference on Dental Implants" (NIH, 1988) providing a comprehensive summary of scientific data.
  • Zarb's 10-year Toronto study concluding the "predictable and reliable" nature of the Branemark implant technique.
  • Gottherer and Singer's report on effective means for preliminary stabilization of full denture patients.
• Material Specifications: Stating that all metals meet ASTM specifications (ASTM F-136 for titanium (ELI) alloy and ASTM F 67-95 for pure titanium), which demonstrates material quality but not device performance against functional acceptance criteria.

In summary, this document does not contain the specific study design and results typically associated with proving a device meets predefined acceptance criteria for performance. It relies on established equivalence to predicate devices and the long history of clinical use and literature supporting the materials and general technology.

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