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510(k) Data Aggregation
(189 days)
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.
The CR Abutment is an abutment placed over Neodent Zirconia Implants in order to provide support for prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are cement-retained in esthetical areas over implants installed in maxilla or mandible.
- Intended for single use;
- Provided sterile via Ethylene Oxide;
- . All devices of Zirconia Implant System are manufactured of Y-TZP (Yttrium-stabilized zirconium dioxide);
- . The CR Abutment for Zirconia system is supplied along with a titanium alloy screw (ASTM F136);
- ZiLock prosthetic interface with internal indexer;
- Apically tapered implant with trapezoidal thread profile;
- Implant provided with sand-blasted, acid etched surface finish;
- . The subject Implants are compatible with the Zirconia Bases (already cleared per market per K201491) and CR Abutments (subject of this submission);
- . The subject CR Abutments are compatible with the Zirconia Implants 4.3 mm (already cleared per market per K201491) and Zirconia Implants 3.75 mm (subject of this submission).
This document describes the Neodent Implant System - Zirconia Implant System (K210336), which includes Zirconia Implants and CR Abutments. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly refer to "acceptance criteria" in the traditional sense of numerical thresholds for a study endpoint. Instead, the performance data presented aims to demonstrate equivalence to predicate devices through various tests.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 and ISO 10993-18. Not representing a new worst-case compared to K201491. | Biological Safety Assessment guided by ISO 10993-1 performed. Chemical characterization per ISO 10993-18 performed. Subject devices do not represent a new worst-case, relying on results from K201491. |
| Dynamic Fatigue Test | Equivalent fatigue strength to predicate devices per ISO 14801 and FDA Guidance. | Performed according to ISO 14801. Devices exhibit a level of performance equivalent to that reviewed for the predicate devices. SEM images after fatigue show similar wear to K201491. |
| Torsion Test | Sufficient resistance to static torsional loading. | Performed to evaluate the Zirconia Implant System under static torsional loading. (Specific quantitative results not provided in this summary). |
| Insertion Test | Acceptable insertion torque into different bone types. | Performed to evaluate insertion torque into sawbones material representing bone types I, II, III, and IV. (Specific quantitative results not provided in this summary). |
| Screw Torque Testing | No visible failure after torque application and removal. | Performed with torque application and visual analysis. No visible failure identified after applying torque and removing items. Subject screws considered equivalent to those cleared per K201491. |
| Sterilization Validation | Sterility Assurance Level (SAL) of 1x10^-6 via Ethylene Oxide (ISO 11135-1). Not representing a new worst-case compared to K201491. | Sterilized by Ethylene Oxide per ISO 11135-1 (over-kill method). Achieved an SAL of 1x10^-6. Subject devices do not represent a new worst-case, adopting the method from K201491. |
| Bacterial Endotoxin Testing | Results < 0.05 EU/device per ANSI/AAMI ST72:2011. | Performed on representative samples. Obtained results were <0.05 EU/device. |
| MR Conditional Labeling | Leveraging of existing K182620 labeling. | MR Conditional Labeling was leveraged from K182620. |
| Shelf Life | 5 years of product and package stability. | Validated per ASTM F1980. Shelf life determined to be 5 years. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific numerical sample sizes for each individual test conducted for the subject device. It refers to "representative samples" for biocompatibility and bacterial endotoxin testing, and studies conducted based on "FDA Guidance" and ISO standards.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer, JJGC Indústria e Comércio de Materiais Dentários SA, is located in Curitiba, Parana, Brazil.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided in the document. The document describes engineering and laboratory testing for device performance, not a clinical study involving diagnosis or interpretation by experts to establish ground truth.
4. Adjudication Method:
This information is not applicable and not provided in the document. As mentioned above, it's not a clinical study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
No, this question is not applicable. The device is a physical dental implant system, not a software algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the performance tests is derived from established engineering standards, material specifications, and regulatory guidance. For example:
- Biocompatibility: ISO 10993 standards and a comparison to previously cleared (predicate) device data.
- Mechanical Testing: ISO 14801 standard and comparison to predicate device performance.
- Sterilization: ISO 11135-1 standard achieving a specific SAL.
- Bacterial Endotoxin: ANSI/AAMI ST72:2011 standard.
- Shelf Life: ASTM F1980 standard.
8. The Sample Size for the Training Set:
This information is not applicable as the device 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:
This information is not applicable as the device is a physical medical device, not an AI/ML algorithm.
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