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TUF LiNK Silicone Reliner is applied to acrylic dentures for the purpose of providing a soft tissue-bearing surface to the denture for patient comfort.

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This document is an FDA 510(k) clearance letter for a medical device called "Tuf Link™ Resilient Silicone Reliner." It does not contain any information about acceptance criteria, device performance metrics, clinical studies, sample sizes, expert qualifications, or ground truth establishment.

The letter is a regulatory document stating that the FDA has found the device to be "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It refers to general controls, regulations, and advises the manufacturer on their responsibilities for registration, labeling, and good manufacturing practices.

Therefore, I cannot provide a response to your request based on the provided text, as the necessary information is not present.

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The Dentatus Osciomat is intended for use in preparing bone in conjunction with dental and craniofacial surgical procedures.

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This document is a 510(k) premarket notification letter from the FDA for a dental device called the "Dentatus Osciomat." It primarily focuses on regulatory approval and does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance.
3. Number and qualifications of experts.
4. Adjudication method.
5. MRMC comparative effectiveness study.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval letter, confirming that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has been deemed safe and effective based on existing devices, not necessarily a new clinical study with performance metrics in this specific filing.

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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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This looks like a summary of a 510(k) submission for a medical device called "Dentatus MTI™ Anchor Post," which is an endodontic splint.

However, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria. The document focuses on:

• Classification and identification of the device.
• A brief literature review asserting the safety and effectiveness of endodontic splints in general, not specifically the Dentatus MTI™ Anchor Post through a dedicated study.
• Substantial equivalence claims to pre-amendment devices and previously cleared devices, which is a regulatory pathway that often bypasses the need for new, extensive clinical studies if a device is sufficiently similar to existing ones.
• Technology details confirming it uses established materials and manufacturing methods.

Therefore, I cannot populate the table or answer your specific questions with the information provided. The document explicitly states: "Endodontic splints made of titanium or titanium alloy have V. been proved safe and effective through the years," implying reliance on general historical use and existing literature rather than a new study for this specific device.

If you have a different document that details acceptance criteria and performance studies for the Dentatus MTI™ Anchor Post, please provide that.

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