(88 days)
The FRIALIT-2® Dental Implant System is intended for use in single tooth restoration, edentulous spans restored with multiple single teeth, free-standing bridges and to retain overdentures. The implants can be used after extraction for immediate implant placement, delayed immediate implant placement or late implant placement.
The FRIALIT-2® 3.4mm Dental Implant is an addition to the FRIALIT-2® Dental Implant System currently in commercial distribution. The FRIALIT-2® 3.4mm dental implant is available as a stepped cylinder coated with either FRIOS® TPS (titanium plasma sprayed) coating or FRIOS® HA (hydroxylapatite) coating, and a stepped screw-type implant line coated with the FRIOS® Deep Profile Surface. Surgical, prosthetic and laboratory components to facilitate the placement and restoration of the 3.4mm implant have also been designed.
This document describes the FRIALIT-2® 3.4mm Dental Implant and its substantial equivalence to predicate devices, rather than a study with acceptance criteria and device performance. Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample sizes, expert qualifications, ground truth, or MRMC studies.
The document focuses on demonstrating that the new 3.4mm implant system is substantially equivalent to existing FRIALIT-2® systems and the Nobel BioCare Branemark 3.75mm dental implant based on design, materials, coatings, prosthetic options, functionality, mechanical strength, and intended use.
Here's what can be extracted:
Acceptance Criteria and Device Performance:
No specific "acceptance criteria" with numerical targets or "reported device performance" metrics are provided in the traditional sense of a clinical or analytical study. Instead, the "acceptance criteria" are implied by the substantial equivalence argument, meaning the device must be comparable to the predicate devices in the following aspects:
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Reference to Predicate Devices) |
|---|---|
| Design | Equivalent to current FRIALIT-2® Dental Implant Systems and Noble BioCare Branemark 3.75mm dental implant. |
| Materials | Equivalent to current FRIALIT-2® Dental Implant Systems and Noble BioCare Branemark 3.75mm dental implant. |
| Coatings | Equivalent to current FRIALIT-2® Dental Implant Systems. |
| Prosthetic Options | Equivalent to current FRIALIT-2® Dental Implant Systems. |
| Function | Equivalent to current FRIALIT-2® Dental Implant Systems and Noble BioCare Branemark 3.75mm dental implant. |
| Intended Use | Equivalent to current FRIALIT-2® Dental Implant Systems and Noble BioCare Branemark 3.75mm dental implant. |
| 30° Compression/Bending Testing | Substantially equivalent to Nobel BioCare Branemark 3.75mm dental implant. |
| Cyclic Loading Fatigue Testing | Substantially equivalent to Nobel BioCare Branemark 3.75mm dental implant. |
Missing Information:
The following information is not present in the provided text, as the document is a 510(k) summary focused on substantial equivalence rather than a detailed study report:
- Sample sizes used for the test set and data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth establishment for a test set is mentioned.
- Adjudication method for the test set: No test set or adjudication process is described.
- Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device, not an algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a substantial equivalence claim for a physical device.
- Sample size for the training set: Not applicable, as this is not a machine learning study.
- How the ground truth for the training set was established: Not applicable.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.