(211 days)
Indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
The Reliadent Dental Implant System includes surgical implants, healing cap, restoration abutments, and surgical instruments.
Implants: Includes one or two step dental implant devices which are designed as conical and cylindrical shapes. They consist of various diameters with a range of 3.6mm-6.0mm and lengths with a range of 8mm-17mm. The internal and external hexagonal shapes are important to maintain the implant stability. One group of the products is HA coated. This surface has been modified to enhance the osseointegration. The dental implants are composed of medical grade 4 pure titanium.
Cover screw and healing cap: The cover screw and healing caps are supplied together with the implants. They cover the internal body of implant to allow gum free space for connection between the implants and restoration abutments.
Abutment: Abutments and accessories are the support part to prosthetic restoration. Screw retained abutments are included in the Reliadent Dental Implant System. The abutments are composed of medical grade 2 titanium.
Surgical Instrument Kit: The surgical instruments include the implants installation set, abutment connections, and drill set. There are hand tools, drill bits of different sizes, and handles in these sets. The instrument kit is designed to be used with a wide range of commercially available implant devices.
The provided text is a 510(k) summary for the Reliadent Dental Implant System. It primarily focuses on demonstrating substantial equivalence to a predicate device based on similar intended use, materials, and design. This type of document generally does not include detailed acceptance criteria or extensive study data comparing performance against specific metrics. Instead, it relies on inferring equivalent performance based on similarities to a device already on the market.
Therefore, for the specific questions regarding acceptance criteria and studies proving the device meets them, much of the requested information is not present in the provided document.
Here's an analysis based on the available information:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly stated in the document.
The 510(k) summary asserts "equivalent performance characteristics" to the predicate device, but it doesn't define specific acceptance criteria (e.g., minimum tensile strength, fatigue life, osseointegration rates) or present a table of results directly from tests on the Reliadent device against such criteria. The "performance" is primarily inferred from the similarities in design, materials, and intended use as compared to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided.
The document does not describe a "test set" in the context of a performance study with specific data points. The assessment is qualitative, comparing the Reliadent Dental Implant System to the MIS Dental Implant System. There is no mention of a prospective or retrospective study, nor any country of origin for specific data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable/Not provided.
No ground truth establishment process for a test set is described. The equivalency claim is based on the submitter's assertion and FDA's review of the submission.
4. Adjudication Method for the Test Set
Not applicable/Not provided.
Since no specific test set or multi-reader evaluation is described, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No.
There is no mention of an MRMC study or any study involving human readers. This device is a dental implant system, not an imaging or diagnostic device that would typically involve human reader studies.
6. Standalone (Algorithm Only) Performance Study
No.
This device is a physical medical device (dental implant system), not an algorithm or AI software. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
Not applicable/Not provided in the context of performance data.
The "truth" in this submission relies on the established safety and effectiveness of the predicate device (MIS Dental Implant System) and the argument that the Reliadent system is substantially equivalent. There's no mention of using pathology, outcomes data, or expert consensus to establish a "ground truth" for a performance study of the Reliadent device itself.
8. Sample Size for the Training Set
Not applicable/Not provided.
As this is a physical medical device and not an AI/ML algorithm requiring training data, the concept of a "training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided.
Since there's no training set, there's no ground truth establishment process for it.
Summary of what the document does provide regarding "proof":
The "proof" for the Reliadent Dental Implant System's safety and effectiveness in this 510(k) summary is based on substantial equivalence to an already legally marketed predicate device (MIS Dental Implant System, K040807).
The key arguments for substantial equivalence are:
- Same Intended Use: "Indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function." This is identical to the predicate's intended use.
- Similar Performance Characteristics: The document states the predicate has "equivalent performance characteristics in its intended use, material and design." For the Reliadent system, it asserts "All other technological characteristics are similar and both devices show equivalent performance capabilities."
- Similar Design and Materials: Both systems include implants (conical/cylindrical shapes, various diameters/lengths, internal/external hexagonal shapes), cover screws/healing caps, abutments, and surgical instruments. Both use medical grade pure titanium, with the Reliadent system specifying grade 4 for implants and grade 2 for abutments.
- One Differentiating Feature: The Reliadent system "is substantially the same as the currently marketed MIS dental implant with a modified surface. This surface promotes osseointegration." The implication is that this modification enhances a desirable characteristic (osseointegration) without introducing new safety or effectiveness concerns, and thus does not alter the substantial equivalence.
In conclusion, the provided document is a regulatory submission for substantial equivalence, not a detailed scientific study report with specific acceptance criteria and performance data from clinical trials or bench testing for the Reliadent device itself. The evidence for meeting criteria is indirect, rooted in its similarity to a predicate device.
§ 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.)