(224 days)
Ti-Base for individual Zirconium Abutments: The devices covered by this submission are abultments which are placed into a dental implant to provide support for a prosthetic restoration.
The Ti-Base for individual Zirconium Abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Ti-Base abutments are indicated for use with the following implant systems:
- Nobel Biocare® Replace Select® .
- Nobel Biocare NobelActive TM .
- Biomet 3i® Osseotite® .
- Biomet 3i® Osseotite® Certain® .
- Nobel Biocare Branemark® ●
- Straumann® synOcta® .
- Straumann® Bone Level® .
- Zimmer® Tapered Screw-vent® .
- Astra Tech OsseoSpeed® .
- Dentsply-Friadent® Frialit® .
2-CONnect Abutment for Bridges and Bars: 2-CONnect for Bridges and Bars is indicated for use to provide support for prosthetic restorations such as bars and bridges. The 2-CONnect abutments can be used in multiple tooth restorations. The 2-CONnect abulment can be used together with cemented bridges and bar constructions for functional and aesthetical reconstruction. The 2-CONnect abutments are indicated for use with the following implant systems:
- Nobel Biocare® Replace Select® .
- Straumann® synOcta® .
- Straumann® BoneLevel® .
The Ti-Base Abutment is a premanufactured prosthetic component supplied in two parts, the abutment and screw, for fixation onto dedicated endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.
The 2-CONnect Abutment consists of 1 Abutment with screw (for fixation of abutment to the implant) and 1 titanium cap with 1 tiny screw (fixed into the hollow Abutment screw). The cap on top fits exactly to the abutment-geometry and does not have a rotation fixation, so it is easier to work with (not indicated for single crowns but strictly for bridges). The 2-CONnect is intended for use as an aid in prosthetic rehabilitation.
The NT-Trading Ti-Base and 2-CONnect is compatible, with commercially available dental CAD/CAM systems, such as 3Shape, Exocad, Dental Wings. Such systems must be validated by the user.
This K111935 510(k) submission describes the acceptance criteria and study for the NT-Trading Ti-Base Abutment and 2-CONnect Abutment, which are dental abutments.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Summary of Testing) |
|---|---|
| Fatigue Testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous implants | Fatigue testing was performed on the abutments with the implants they are intended to fit. The results demonstrated compatibility and substantial equivalence to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Testing was performed on the abutments in this submission with the implants that they are intended to fit." However, the exact sample size (number of abutments/implants tested) and the data provenance (e.g., country of origin of the data, retrospective or prospective) are not specified in the provided 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission pertains to a medical device (dental abutments) and relies on engineering and performance testing (fatigue testing) rather than a clinical study with a "ground truth" established by human experts in the context of diagnostic performance. Therefore, the concept of "experts establishing ground truth" as it applies to diagnostic studies is not applicable here. The "ground truth" for this device is its physical performance under specified standards.
4. Adjudication Method for the Test Set
As this is a performance study based on engineering standards (fatigue testing), an adjudication method in the context of human expert disagreement is not applicable. The results are based on objective measurements and predefined pass/fail criteria according to ISO 14801.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This is a performance study for a physical device, not a diagnostic or AI-assisted interpretation study. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone "algorithm only" performance study was not done. This device is a physical dental abutment, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for this study is based on engineering standards and objective physical measurements in a laboratory setting, specifically fatigue testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous implants.
8. The Sample Size for the Training Set
The provided document describes a device subject to performance testing, not a machine learning model. Therefore, the concept of a "training set" and its sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device, the question of how its ground truth was established is not applicable.
§ 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.)