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510(k) Data Aggregation
(136 days)
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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(69 days)
The SICace System Dental Implant is a root form endosseous dental implant system that is indicated to be implanted in the upper and/or lower jaw arches. The implants may be used in combination with various SICace System Abutments for single or multiple unit prosthetic attachment to restore a patient's chewing function.
Patient's must be applicable for dental treatment with endosseous implants.
In cases where the ridge is too narrow to receive a 4.0 mm or a 5.0 mm diameter implant, the 3.4 mm implant can be used. Because of reduced strength due to the small diameter, these implants should be rigidly joined to other implants and used only where loads are not extreme.
The SICace System Abutment is intended to be placed into the SICace System Implant to provide a safe and effective fit of screw retained and/or cementable crowns and bridges.
SICace dental implant system is a root-form endosseous dental implant device made out of grade 4 titanium according ASTM F 67. The implants are available in three different diameters (ø3.4 mm, ø4.0 mm, ø5.0 mm) and various lengths from 9.5 mm. The anchorage surface is grit blasted and acid etched for faster osseointegration and secondary stability.
Equal to the predicate device SICpro dental implant, the face side of the SICace dental implant has a hexagon drill hole and a standard screw thread to ensure and anti-rotational connection of the congruent abutment and the implant. Throughout the different diameters the hexagon drill hole has identical measurements.
SICace dental implants are delivered single packed in combination with an implant cover screw and supplied in sterile condition (sterilized by gamma-radiation).
SIC angled abutments are various in lengths and diameters and made out of titanium ASTM F 136. Through a hexagon socket and a vertical drill hole, the abutments can be connected with the implant secure and anti-rotational.
SIC angled abutments are supplied in non sterile condition. These parts of the system can be sterilized by the user by using a standardized and validated sterilization process.
The provided text does not contain information about acceptance criteria for device performance, a study to prove meeting acceptance criteria, or any of the detailed study parameters (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).
The document is a 510(k) summary for the SICace Dental Implant System, focusing on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study data against specified acceptance criteria. It describes the device, its classification, predicate devices, and indications for use, ultimately concluding that it is substantially equivalent.
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(275 days)
The FRIALIT® PLUS Dental Implant System is indicated for use in single tooth restorations, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used for immediate implant placement, delayed immediate or late implant placement.
The XiVE®S PLUS Dental Implant System is indicated for the following: Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations. In the edentulous mandible, a minimum of four XiVE® dental implants (≥9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.
The XiVE® D3.0 PLUS Dental Implant System is indicated for single tooth restorations and splinted tooth restorations in the region of 7 to 10 and 23 to 26.
The XiVE® TG PLUS Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular splinted crowns, bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants. In the edentulous maxilla, a minimum of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together. In the edentulous mandible, a minimum of four transgingival implants (≥9.5mm length) are placed between the mental foramina and rigidly splinted together. In this case, bar prosthetic loading is possible immediately after implant placement.
The FRIALIT®, XiVE® and XiVE® TG dental implants with the new FRIADENT Surface have been cleared for commercial distribution. The purpose of this application is to change the name of the surface to PLUS and obtain clearance for additional marketing claims associated with the PLUS surface.
This 510(k) summary describes a modification to an existing dental implant system, specifically changing the surface name to "PLUS" and seeking clearance for associated marketing claims. As such, the submission focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing de novo performance criteria against acceptance thresholds.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (As Implied by Substantial Equivalence and Preclinical/Animal Studies) | Reported Device Performance |
|---|---|---|
| Biocompatibility/Surface Characteristics | The "PLUS" surface should exhibit favorable physiochemical surface characteristics and support osseointegration comparable to or better than existing FRIADENT surfaces and other commercially available surfaces. | Preclinical evaluations at the University of Tubingen, Germany, compared physiochemical surface characteristics to other commercially available surfaces. Animal studies (University of Cologne, Germany; University of São Paulo, Brazil) evaluated loaded and unloaded implants, immediate placement in infected sites, and the effect of laser therapy on osseointegration. Conclusion: "Results of these studies support the PLUS surface characteristics, name and advertising claims for the FRIADENT Dental Implant Systems." Specific mention of "higher removal torque values compared to solely acid-etched implants and anodic oxidized textured implants" after 5 months, interpreted as "an increase in the strength of endosseous implant integration and implant stability." |
| Mechanical Strength | Maintain mechanical strength comparable to existing FRIADENT dental implant systems. | Stated that the new systems are "substantially equivalent to the current FRIADENT® Dental Implant Systems in terms of... mechanical strength." |
| Intended Use | The modified devices should remain suitable for their indicated uses (single tooth restorations, bridges, overdentures, various implant placement timelines). | The intended uses for the FRIALIT® PLUS, XiVE® S PLUS, XiVE® D3.0 PLUS, and XiVE® TG PLUS systems are clearly outlined and align with general dental implant applications. |
| Safety and Effectiveness | The device should be safe and effective for its intended use, demonstrating substantial equivalence to predicate devices. | The submission provides a "Class III certification and summary of adverse safety and effectiveness information pursuant to 513(f) of the Federal Food, Drug, and Cosmetic Act." The overall conclusion is that "Comparison of the FRIADENT dental implant systems to the predicate device shows that the device is substantially equivalent." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of implants or subjects. The studies were preclinical and animal studies.
- Data Provenance:
- Country of Origin: Germany (University of Tubingen, University of Cologne) and Brazil (University of São Paulo).
- Retrospective or Prospective: Not explicitly stated, but preclinical and animal studies are typically prospective in their design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable in the context of this 510(k) summary. The "ground truth" for these types of studies is derived from objective measurements (physiochemical analysis, biomechanical testing, histological evaluation in animal models) performed by researchers at the respective universities, not through expert consensus on interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert interpretations (e.g., medical imaging). The studies involved laboratory and animal experiments with quantifiable outcomes.
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 submission is for a dental implant system (hardware), not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or software device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" was established through:
- Physiochemical surface analyses: Laboratory measurements of surface properties.
- Histological and biomechanical analyses in animal models: Evaluation of osseointegration, bone-implant contact, and removal torque values in vivo. This is akin to "pathology" or objective biological outcomes in an animal setting.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-driven device requiring a training set. The studies described are traditional preclinical and animal investigations.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not an AI/ML device.
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