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510(k) Data Aggregation
(136 days)
TDS ABUTMENT FOR FRIADENT XIVE
TDS Abutment for Friadent Xive is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
This device is compatible with the following implant systems which have an internal hex with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Internal Connect Type; Astra: Osseospeed Implant, Osseospeed TX Implant; BioHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System, Laser-lok® 3.0 implant system; Lifecore: Lifecore RENOVA™ Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System; Osstem: GS System; Nobel Biocare: Active Implant.
TDS Abutment for Friadent Xive are titanium and ceramic-titanium abutments designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Abutment for Friadent Xive is compatible with the following implant systems which have an internal hex with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Internal Connect Type; Astra: Osseospeed Implant, Osseospeed TX Implant; BirHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System, Laser-lok 3.0 implant system; Lifecore: Lifecore RENOVA™ Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System; Osstem: GS System; Nobel Biocare: Active Impalnt.
The provided document describes the K103339 510(k) Premarket Notification for the "TDS Abutment for Friadent Xive." This device is a dental implant abutment.
Here's an analysis of the acceptance criteria and the study conducted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength | Mechanical testing, according to ISO 14801 Dentistry - Fatigue test for endosseous dental implants, was conducted on a worst-case scenario with an angle abutment. |
| Result: The testing results show that TDS Abutment for Friadent Xive made of titanium, zirconia-titanium, and zirconia materials for their respective dental implant systems have sufficient mechanical strength for their intended clinical application. | |
| Compatibility with Implant Systems | Compatibility testing was conducted on the abutments and corresponding dental implants with designated screws. The dimensions, tolerances, and rotation parameters were evaluated to determine appropriate fit. |
| Result: The testing results show that TDS Abutment for Friadent Xive is compatible with the implant systems for which it is indicated for use (listed in the "Intended Use" section: Firadent, 3i, Astra, BioHorizons, Lifecore, Zimmer, Osstem, Nobel Biocare systems with internal hex ≥ 1.78mm flat-to-flat dimensions). | |
| Material Equivalence (Implicit) | The device incorporates "the same materials" as predicate devices (Ti-6Al-4V ELI and Y-TZP Zirconia for abutment, Ti-6Al-4V ELI for screw if provided by manufacturer). |
| Design and Operating Principle Similarity | The device "incorporates the same basic design" and "uses the same operating principle" as predicate devices. |
| Manufacturing Process Similarity | The device "is produced using the same processes" as predicate devices. |
| Intended Use Equivalence | The device "has the same intended use" as predicate devices. (Support for single or multiple tooth prostheses in maxilla or mandible of partially or fully edentulous patients). |
Summary of Study: The primary study conducted was non-clinical testing focusing on mechanical strength and compatibility.
The document does not suggest an AI/ML device. Therefore, the following points are not applicable to the provided information.
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, as this is a mechanical medical device, not an AI/ML device, and no clinical data (test set) is described in the provided summary. The testing was non-clinical.
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, as this is a mechanical medical device, not an AI/ML device. Ground truth, in the context of expert consensus for medical imaging, is not relevant here. The "ground truth" for mechanical performance is established by standardized testing protocols (ISO 14801).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is a mechanical medical device, not an AI/ML device with a human-adjudicated test set.
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, as this is a mechanical medical device and not related to AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is a mechanical medical device and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical strength testing, the "ground truth" or the success criteria would be defined by the acceptance limits specified in the ISO 14801 Dentistry - Fatigue test for endosseous dental implants standard. For compatibility testing, the "ground truth" is appropriate fit based on measured dimensions, tolerances, and rotation parameters. This is a technical standard-based ground truth.
8. The sample size for the training set
Not applicable, as this is a mechanical medical device and not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is a mechanical medical device and not an AI/ML device.
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(75 days)
TDS ABUTMENT FOR NOBEL BIOCARE REPLACE
TDS Abutment for Nobel Biocare Replace is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
TDS Abutment for Nobel Biocare Replace is compatible with the following implant systems: Nobel Replace® Select Straight, Nobel Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage, Nobel Replace Straight, Nobel Replace Tapered, Nobel Replace Straight Groovy, and Nobel Replace Tapered Groovy for the 3.5 mm (NP), 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) implants.
Note: Highly angled abutments (i.e. 30°) on implants with diameters less than 4 mm are not intended for the posterior region of the mouth due to limited strength of the implant.
TDS Abutment for Nobel Biocare Replace are titanium and ceramic-titanium abutments designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is made of Ti-6A1-V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Abutment for Nobel Biocare Replace are compatible with Nobel Replace® Select Straight, Nobel Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage, Nobel Replace Straight, Nobel Replace Tapered, Nobel Replace Straight Groovy, and Nobel Replace Tapered Groovy for the 3.5 mm (NP), 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) implants.
This document is a 510(k) Premarket Notification for a dental implant abutment (TDS Abutment for Nobel Biocare Replace). It is a regulatory submission to demonstrate substantial equivalence to legally marketed predicate devices, not a study reporting on the performance of the device against specific acceptance criteria.
Therefore, the requested information (acceptance criteria, device performance, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, and training set information) is not present in the provided text.
The document primarily focuses on:
- Administrative Information: Manufacturer, contact, device names, classification.
- Intended Use: What the device is designed for.
- Device Description: Materials, compatibility with specific implant systems.
- Equivalence to Marketed Device: Asserting substantial equivalence to existing predicate devices.
- FDA Communication: A letter from the FDA affirming the substantial equivalence determination and outlining regulatory obligations.
- Indications for Use: Formal statement of the device's indications.
The FDA's substantial equivalence determination means they believe the new device is as safe and effective as a legally marketed predicate device, not that specific performance metrics against an acceptance criterion were reported in this submission or that a large-scale clinical study was conducted. For this type of device, substantial equivalence is often established through material testing, mechanical testing, and comparison of design features and intended use to predicate devices, rather than through extensive clinical trials with detailed performance metrics like sensitivity/specificity.
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(182 days)
TDS ABUTMENT
TDS Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
TDS Abutments are custom titanium or ceramic abutments designed to be used in conjunction with specific dental implants utilizing the screw provided by the implant manufacturer. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Abutments made of titanium are available for Nobel Biocare Replace® RP (Ø 4.3 mm) implants. TDS Abutments made of ceramic are available for Nobel Biocare Replace® WP (Ø 5.0 mm) implants and BioHorizons Internal 4.0 (Ø 4.5 mm platform) implants.
This document is a 510(k) premarket notification for a dental device, the TDS Abutment. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device) and does not require premarket approval (PMA). The key aspect of a 510(k) submission is establishing substantial equivalence to an existing predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies.
Therefore, I cannot provide the requested information from this document because it is not present in the provided text. The document focuses on administrative information, device description, and the FDA's clearance decision based on substantial equivalence.
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