(296 days)
The Klockner Dental Implant Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges or overdentures. The Klockner Dental Implant Abutments include healing caps, temporary abutments, angled abutments, straight abutments, and overdentures. All abulments are intended to be used with the Klockner Dental Implant Systems, models: Essential EC, Essential ECK, Essential ECK, Essential EC 1.5, SK2 and NK2.
Klockner Dental Implant Abutments consist of a group of prosthetic components placed into dental implants to aid in prosthetic rehabilitation. According to their function, they are classified in:
- Healing caps, are manufactured in Titanium Alloy, intended to assist in healing or modification of the adjacent tissues for internal octagonal connection system.
- Protective caps, manufactured in PMMA and Titanium Alloy intended to protect abutments when choosing direct oral impression for internal octagonal connection system.
- Temporary abutments, manufactured in Titanium cp, Titanium Alloy and Titanium cp + -PMMA, intended to support provisional prosthetic restorations for internal octagonal connection system.
- Angled abutments, manufactured in Titanium cp and Titanium Alloy, intended to retain definitive dental prosthesis. Used when it is necessary to correct the implant axis, for internal octagonal connection system and external hexagonal connection system.
- Straight abutments, manufactured in Titanium Alloy and Titanium cp, intended to retain definitive dental prosthesis for internal octagonal connection system. Includes Titanium Octacone Scan abutment, a Titanium Base for CAD/CAM. This base is suitable for precision fit custom abutments or crown and bridge restorations fabricated with CAD/CAM technology provided separately by 3M ESPE as the Lava System.
- Overdenture abutments, manufactured in Titanium Alloy and POM C, intended to retain removable dental prosthesis for internal octagonal connection system and external hexagonal connection system.
Healing caps, protective caps and temporary abutments are used for a limited time, while angled abutments, straight abutments and overdenture abutments are intended for a definitive use.
This is a 510(k) premarket notification for KLOCKNER Dental Implant Abutments. This document primarily focuses on establishing substantial equivalence to predicate devices based on material, design, and intended use, rather than presenting a clinical study with detailed acceptance criteria and performance metrics for a novel AI/ML device.
Therefore, many of the requested points, particularly those related to AI/ML device performance, ground truth, expert adjudication, and sample sizes for training/test sets, cannot be extracted from this document because they are not applicable to the type of device and submission presented.
Here's an analysis of the provided text based on the questions, noting where information is not applicable or available:
1. A table of acceptance criteria and the reported device performance
This document does not present quantitative acceptance criteria or device performance metrics for a novel device in the way a clinical study for an AI/ML device would. The submission aims to establish "substantial equivalence" based on similar materials, design, and intended use to existing predicate devices.
The "acceptance criteria" for a 510(k) submission are typically related to demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through comparisons to predicate devices and bench testing.
- Bench Testing: The document states, "The results of bench testing confirm acceptable device performance as per its intended use." Specific performance values or acceptance criteria for these bench tests (e.g., torsion, fatigue testing according to ISO 14801) are not provided in this summary.
- Sterilization: "A sterilization according ISO 17665-1 was carried out to confirm the recommended sterilization."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for dental implant abutments, not an AI/ML device requiring a test set for diagnostic performance evaluation. The "testing" referred to is bench testing on the physical device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. There is no "ground truth" establishment in the context of an AI/ML device for this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set for diagnostic performance evaluation is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. There is no "ground truth" in the context of an AI/ML device for this submission. The "truth" for substantial equivalence rests on comparison to predicate devices and standard engineering/material testing.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. As above, this pertains to an AI/ML device, which this is not.
Summary of available information:
- Device: KLOCKNER Dental Implant Abutments (healing caps, protective caps, temporary abutments, angled abutments, straight abutments, overdenture abutments).
- Intended Use: To be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges, or overdentures.
- Study Type: 510(k) premarket notification for substantial equivalence. The "study" involves comparison to predicate devices and bench testing.
- Acceptance Criteria & Performance:
- Demonstration of substantial equivalence to predicate devices (K080224, K082200, K010132, K062129, K071585, K033243, K071357, K050705, K992334, K060291, K072624, K092248, K101798, K083876, K102804, K072055). This involves comparing indications for use, basic design, operating principles, material, and packaging.
- Bench testing for torsion and fatigue (according to ISO 14801) under worst-case conditions.
- Bioburden and sterility testing (in accordance with ISO 11737-1 and ISO 17665-1).
- The document explicitly states: "No clinical data are presented in this submission."
- Data Provenance: The document does not discuss clinical data or patient data. The "data" are from non-clinical bench tests and comparisons to specifications of predicate devices.
- Conclusion: The submitter believes the device is substantially equivalent to predicate devices, and bench testing confirms acceptable performance for its intended use. The FDA concurred with this determination.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)