(270 days)
The Klockner Dental Implant Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges. The Klockner Dental Implant Abutments include protective cap, temporary abutment, angled abutments, straight abutments, cast abutments are intended to be used with the Klockner Dental Implant Systems, models: Essential EC, Essential EC 1.5.
Klockner Dental Implant Abutments (II) consist of a group of prosthetic components to be used with dental implants as an aid in prosthetic rehabilitation. According to their function, they are classified in:
- Protective cap, made of titanium alloy, intended to be provisionally connected to dental abutment as a protection when choosing direct oral impression on the abutment.
- Temporary abutment, made of titanium alloy, intended to be provisionally connected to dental abutment to retain a provisional screw-retained multiple-unit restoration.
- Angled abutments, made of titanium alloy, intended to be definitively connected to dental implant to enable screw-retained multiple-unit restorations. These abutments, used when it is necessary to correct prosthesis axis with respect to implant axis, are available with different angulation and different transmucosal height, enabling the anatomic characterization of the gum margin and facilitating the prosthetic fitting.
- Straight abutments, made of titanium alloy, intended to be definitively connected to dental implant to enable screw-retained multiple-unit restorations, with not correction of implant angulation. These abutments are available with different transmucosal height, enabling the anatomic characterization of the qum margin and facilitating the prosthetic fitting.
- Cast abutments, made of gold alloy and Co-Cr-Mo alloy, intended for cement-retained single- unit and multiple-unit restorations and for screw-retained single-unit restorations on dental implants using the casting technique.
All these abutments are designed for Klockner Dental Implant Systems, models Essential EC (K080224) and Essential EC 1.5 (K082200), with internal octagonal cone connection.
The document is a 510(k) premarket notification for the Klockner Dental Implant Abutments (II). Based on the provided text, the following information can be extracted regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a clear, summarized format. Instead, it states that "Fatigue testing, conducted according to ISO 14801 and the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, has been performed considering worst-case conditions." It then reports that "Results obtained show that devices performance is acceptable as per their intended use."
To infer the acceptance criteria and reported performance, we can deduce them from the referenced standard, ISO 14801, which outlines specific fatigue test methods for dental implants. The acceptance criterion for fatigue testing according to ISO 14801 typically involves surviving a certain number of load cycles (e.g., 5 million cycles) at a specified load without fracture or permanent deformation beyond acceptable limits. The reported performance is a general statement that the device met these implicit criteria.
A hypothetical table based on common ISO 14801 requirements would look like this:
| Acceptance Criteria (Implied by ISO 14801) | Reported Device Performance |
|---|---|
| Fatigue Strength: Device must withstand 5 million cycles at a specified load (stress) without fracture or permanent deformation. | "Devices performance is acceptable as per their intended use." (This implies the devices met the fatigue strength requirements of ISO 14801) |
| Corrosion Resistance: (For Co-Cr cast abutments) Confirm high corrosion resistance. | "Test results confirm the high corrosion resistance of Co-Cr-Mo alloy" |
| Galvanic Corrosion: (For Co-Cr cast abutments) Show insignificant galvanic corrosion with unalloyed titanium (Ti c.p.) and titanium alloy (Ti-6Al-4V). | "show an insignificant galvanic corrosion of this material with respect to unalloyed titanium (Ti c.p.) and titanium alloy (Ti-6Al-4V)." |
| Biocompatibility: All materials used in the manufacture must be biocompatible according to ISO 10993-1:2009 and ISO 7405:2008. | "All materials used... have been subject to biological evaluation... according to the requirements of applicable recognized standards ISO 10993-1:2009 and ISO 7405:2008." (Additional biocompatibility testing was not considered necessary as materials are identical to previously cleared devices). |
| Sterilization: Bioburden and sterility testing accordance with ISO 11737-1 and ISO 11737-2. Steam sterilization validation according to ISO 17665-1. | "Klockner Dental Implant Abutments (II) have been subject to bioburden and sterility testing... Steam sterilization validation according to ISO 17665-1 has been carried out." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size for the bench testing (fatigue testing, corrosion tests, etc.). It mentions "worst-case conditions" but no specific number of units tested.
- Data Provenance: The studies are non-clinical (bench testing) performed by SOADCO, S.L., the manufacturer, which is based in Andorra. The data is prospective in the sense that the tests were conducted specifically for this submission, but it's not clinical patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable as the studies are non-clinical bench tests. "Ground truth" in this context refers to standardized measurements and material properties according to recognized standards (e.g., ISO 14801, ISO 10993, ASTM standards). The "truth" is established by the test protocols and the physical properties of the materials and device design, not by expert consensus on observable phenomena.
4. Adjudication Method (for the test set)
Not applicable. This concept typically refers to clinical studies where independent experts review and agree upon diagnoses or outcomes. For bench testing, the results are objectively measured against established scientific and engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical data are included in this submission." This type of study is for clinical evaluations involving human readers and interpretations of medical cases, which is not relevant to this device's non-clinical submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This refers to the performance of AI algorithms. The Klockner Dental Implant Abutments (II) are physical medical devices, not software or AI-based diagnostic tools.
7. The Type of Ground Truth Used
For the non-clinical studies:
- Fatigue Testing: The ground truth is derived from engineering standards and physical principles. Specifically, the ISO 14801 standard provides the methodology and criteria for evaluating the fatigue life of dental implants and abutments.
- Biocompatibility: The ground truth is established by recognized biocompatibility standards (ISO 10993-1:2009 and ISO 7405:2008) and the known properties of the materials used.
- Corrosion Resistance: The ground truth is based on material science and engineering standards (ISO 10993-15, ASTM F746, ASTM G71) for evaluating corrosion and galvanic corrosion.
- Sterilization: The ground truth is based on microbiological testing standards (ISO 11737-1, ISO 11737-2, ISO 17665-1) to ensure the device can be effectively sterilized.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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.)