Search Results

For use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.

These Class III dental implants are supplied sterile, ready for placement by a licensed dentist. There has been no significant change to the prosthetic components.

This document, K962106, is a 510(k) summary for a dental implant system. It primarily describes a modification to an existing device and compares it to its predicate device. This type of regulatory submission (510(k)) for a dental implant system, especially from 1996, typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a controlled clinical study with acceptance criteria and detailed device performance metrics in the way modern AI/software as a medical device (SaMD) clearances do.

Therefore, the requested information pertaining to acceptance criteria and a study proving the device meets them (especially items 1-7, and 9 for a test set) is largely not applicable in the context of this specific 510(k) document. Dental implants are physical devices, and their performance is usually assessed through bench testing, material characterization, and in some cases, limited clinical data focusing on osseointegration and success rates, often compared to historical data or the predicate device.

However, I can extract and infer information relevant to the nature of this submission. Here's a breakdown based on the provided text, highlighting where information is not available or relevant to a SaMD-style submission:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not contain explicit acceptance criteria or a "reported device performance" table in the typical sense for a clinical study comparing performance metrics. 510(k) submissions for physical devices like dental implants in this era focus on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and materials.

The "performance" implied here is that the modified device performs as well as or similarly to the predicate device, specifically regarding its ability to function as a dental implant. The key "performance" aspect mentioned is the addition of "self-tapping capabilities" to the apical portion, which is a design feature rather than a measurable clinical outcome in this context.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable in the context of this 510(k) summary. This document does not mention a "test set" for performance evaluation in the way a clinical study for software or diagnostics would. Instead, it describes a modification to an existing device. Any testing performed would likely have been bench testing or material characterization, for which "test sets" or "data provenance" as defined for clinical studies are not relevant.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. There is no "ground truth" establishment by experts mentioned for a test set in this 510(k) summary.

4. Adjudication Method:

Not applicable. No adjudication method is mentioned, as there is no test set or expert evaluation described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is a physical dental implant, not an AI or software product. Therefore, an MRMC study is not relevant or mentioned.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a physical dental implant, not an algorithm.

7. Type of Ground Truth Used:

Not applicable. There is no "ground truth" mentioned or established in this 510(k) summary. The demonstration of safety and effectiveness for dental implants typically relies on biocompatibility, mechanical testing, and clinical history of similar devices.

8. Sample Size for the Training Set:

Not applicable. This relates to AI/machine learning. This 510(k) summary is for a physical dental implant and does not involve a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As above, no training set or ground truth in this context.

Summary of Device and Regulatory Focus (based on the provided text):

• Device: Spline Dental Implant System (Class III dental implants).
• Modification: Addition of "self-tapping capabilities" to the apical portion of the implant body.
• Key Aspect of Submission: Demonstrating "substantial equivalence" to the predicate device (Calcitek's existing Spline Dental Implant System).
• Basis for Equivalence:
  • Identical intended use.
  • No significant change to prosthetic components.
  • No change to materials.
  • Overall design of implants and prosthetic components are identical to predicate devices (except for the self-tapping feature).
  • Implants are supplied sterile.

This 510(k) document is a classic example of a "traditional" 510(k) submission for a physical medical device seeking to demonstrate that a modified version is as safe and effective as a previously cleared device. It does not contain the types of clinical study data, performance metrics, or "acceptance criteria" formatted as you would find for a modern AI/SaMD product.

Ask a specific question about this device