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Dental burs are intended to drill bone tissue and provisionally soft tissues during, before and after a surgical intervention of dental implants. Endosseous dental implant abutments are intended to model the gingival tissue during the process of healing after the first or second surgery and to be attached to the implant to hold single or multiple teeth restorations.

Dental bur are rotary cutting devices intended to cut hard structures in the mouth, such as teeth or bone. They are also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices. Endosseous dental implant abutments are premanufactured prosthetic component directly connected to the Endosseous dental implant and are intended for use as aids in prosthetic rehabilitation.

The provided submission for K061383, "TRADITIONAL 510 (K) SUBMISSION BTI Dental Implant System Modification," does not contain information regarding acceptance criteria or a study proving that the device meets such criteria.

The submission is a 510(k) for a modified dental implant system (sterile dental drills kit/abutments and caps). The primary focus of this type of submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish specific performance acceptance criteria for a novel device and then prove those criteria are met through a dedicated study.

Here's a breakdown of why this information is absent, based on the provided text:

• Substantial Equivalence Approach: The submission explicitly states, "The modified BTI Dental Implant System is claimed to be substantially equivalent in material, design, and function to BTI Dental Implant System cleared by FDA under 510(k) K022258 on Sep 11, 2003 and 510(k) 053355 on Mar 14, 2006." This indicates that the core approval strategy relies on comparing the new device to existing, already approved devices, rather than establishing de novo performance criteria.
• Lack of Performance Data: The document describes the device, its intended use, and its classification, but it does not present any specific performance metrics (e.g., bone cutting efficiency, abutment stability, wear resistance) that would typically have acceptance criteria. Consequently, there is no study described that would aim to "prove" such criteria were met.
• Focus on Design, Material, and Function: The "CONCLUSION" reiterates: "The modified BTT Dental Implant System is considered to be substantially equivalent in design, material and function to BTI Dental Implant System." This further emphasizes that the evaluation was a comparison of attributes rather than a measurement against new, independent performance benchmarks.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and a proving study, as this information is not present in the provided 510(k) submission.

Summary of missing information:

1. Table of acceptance criteria and reported device performance: Not provided.
2. Sample size for test set and data provenance: Not applicable, as no specific performance test data is presented.
3. Number of experts and qualifications for ground truth: Not applicable, as no ground truth establishment for a performance study is described.
4. Adjudication method for test set: Not applicable.
5. MRMC comparative effectiveness study: Not conducted or reported.
6. Standalone (algorithm only) performance study: Not applicable (this is a physical medical device, not an algorithm).
7. Type of ground truth used: Not applicable.
8. Sample size for training set: Not applicable.
9. How ground truth for training set was established: Not applicable.

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