(130 days)
The Legacy Abutment System is intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients.
The Legacy Abutment System is compatible with implants that have mating diameters, lead-in bevels, internal hex sizes, and 1-72UNF internal threads, as shown in the Zimmer Dental Tapered Screw-Vent Surgical Manual.
Implant Direct LLC will monitor the compatible implants for modifications to ensure future compatibility. In the event of any modification, Implant Direct LLC will either modify the Legacy abutment to ensure compatibility, or cease claiming compatibility to the modified Zimmer Dental Screw-Vent implants.
The Legacy Abutment System consists of cement retained and screw-retained components. All abutments have the same identical interface diameters as the predicate abutments to function with the corresponding mating Screw-Vent Implants manufactured by Zimmer Dental. The cement retained abutments are offered in a straight body with a straight or scalloped prosthetic margin and in an angled body with a scalloped prosthetic margin. The screw-retained abutments are offered in different cuff diameters and heights to accommodate for the different implant interfaces and tissue heights.
This document is a 510(k) summary for the Legacy Abutment System, which is a dental implant abutment. The purpose of this summary is to demonstrate substantial equivalence to a predicate device, the Screw-Vent Dental Implant System (K011028).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not detail specific quantitative "acceptance criteria" for a study in the typical sense of a diagnostic device's performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it presents a comparison analysis to a predicate device, highlighting "technological characteristics" as the basis for demonstrating substantial equivalence. The "performance" here is that the Legacy Abutment System possesses similar characteristics and intended use to the legally marketed predicate device.
| Technological Characteristic | Acceptance Criteria (Implied by Predicate Device) | Reported Device Performance (Legacy Abutment System) |
|---|---|---|
| Intended Use | To be used as a post to support cemented/screw-retained prostheses for crowns, bridges, or overdentures in edentulous or partially edentulous patients. | Same as predicate. (Supports crowns, bridges, or overdentures for edentulous or partially edentulous patients; functions as a foundation for cemented/screw-retained restorations.) |
| Indication | For single or multiple restorations. | Same as predicate. (For single or multiple restorations; multiple unit application for screw-retained.) |
| General Design (Straight/Scalloped) | Hex engaging post without a prosthetic margin. | Hex engaging post with a prosthetic margin. (A minor difference noted, but overall design is "similar" and still deemed substantially equivalent for its function.) |
| General Design (Angled) | Hex engaging angled post without prosthetic margin. | Hex engaging angled post with a prosthetic margin. (A minor difference noted, but overall design is "similar" and still deemed substantially equivalent for its function.) |
| General Design (Screw-Retained) | One-piece abutment that screws inside the implant. | Same as predicate. |
| Cuff Diameters (Straight/Scalloped) | 3.5, 4.5, 5.7, and 6.5 mm. | 4.5, 5.7, and 6.5 mm. (Fewer options than predicate, but within a similar range used to support equivalence.) |
| Implant/Abutment Interface Diameters | 3.5, 4.5, and 5.7mm. | Same as predicate. |
| Material | Titanium Alloy. | Same as predicate. |
| Packaging (Straight/Scalloped) | Screw mount inside a vial closed with a cap. | Scalloped: Screw mount inside a vial closed with a cap. Straight: Abutments attached to a plastic transfer/holder engaged within an inner vial, which along with a screw-mount containing temporary coping, is placed within a larger outer vial and closed with a cap. (Different, but deemed acceptable.) |
| Packaging (Angled) | Screw mount inside a vial closed with a cap. | Same as predicate. |
| Packaging (Screw-Retained) | Screw mount inside a vial closed with a cap. | Attached to a plastic transfer/holder engaged within an inner vial. The inner vial, along with a screw-mount containing the temporary coping, will be placed within a larger outer vial and closed with a vial cap. (Different, but deemed acceptable.) |
| Sterilization | Sterile. | Non-sterile. (A notable difference from the predicate, but acceptable given the nature of the device and likely requiring sterilization by the end-user. This is addressed as not raising additional safety/effectiveness concerns in the conclusion.) |
| Compatibility | Compatible with implants that have mating diameters, lead-in bevels, internal hex sizes, and 1-72UNF internal threads, as shown in the Zimmer Dental Tapered Screw-Vent Surgical Manual. | Same as predicate. (The Legacy Abutment System is designed to have the same identical interface diameters as the predicate abutments to function with the corresponding mating Screw-Vent Implants). The manufacturer commits to monitoring compatible implants for future modifications. |
Study That Proves the Device Meets Acceptance Criteria:
The "study" presented here is a comparison analysis to a legally marketed predicate device (Screw-Vent Dental Implant System, K011028), rather than a clinical trial or performance study typical for novel devices or software. The conclusion states: "The evaluation of the Legacy Abutment System does not raise any additional concerns regarding safety and effectiveness and therefore is considered substantially equivalent to the predicate device."
2. Sample Sizes Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of a dataset for an AI/algorithm, nor does it refer to patient data or a clinical study. The "test" for substantial equivalence is a comparison of product characteristics. Therefore, there is no sample size for an AI test set or specific data provenance information (country of origin, retrospective/prospective). The data provenance is essentially the technical specifications and design characteristics of the Legacy Abutment System and the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study assessing diagnostic performance where expert ground truth is established. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate device, as determined by its FDA clearance. The "experts" involved are likely the engineering and regulatory teams at Implant Direct LLC and ultimately the FDA reviewers (e.g., Chiu Lin, Ph.D., Director, Division of Anesthesiology, General Hospital, Infection Control and Dental Devices) who determined the substantial equivalence. Their qualifications are inherent in their roles within these organizations.
4. Adjudication Method for the Test Set
Not applicable. There is no multi-reader or adjudication process described as this is not a diagnostic performance study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (dental abutment), not an AI algorithm. Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone performance study for an algorithm was not done. This submission is for a physical medical device.
7. Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the demonstrated safety and effectiveness of the legally marketed predicate device (Screw-Vent Dental Implant System, K011028). The new device is evaluated against the established characteristics and intended use of this predicate to determine substantial equivalence, rather than against a specific pathology or clinical outcome dataset for novel performance claims.
8. Sample Size for the Training Set
Not applicable. This is not an AI/algorithm submission that would involve a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned in the context of an AI 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.)