(103 days)
Thommen VARIOeco dental implant abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures.
VARIOeco abutments are titanium dental implant abutments for use with Thommen System dental implants for fabrication of porcelain-fused-to-metal (PFM) restorations. VARIOeco includes two abutment designs, one for single tooth (crown) and one for multi-tooth (bridge) restorations. A laboratory burn-out cap and abutment screw are provided together with the abutment in the VARIOeco set. Both VARIOeco abutment designs are provided in five platform diameters (3.5, 4.0, 4.5, 5.0 and 6.0 mm) corresponding to Thommen System dental implants (ELEMENT, CONTACT and ONETIME).
This document is a 510(k) summary for the Thommen Medical AG VARIOeco dental implant abutment. It establishes substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a formal study with statistical endpoints. Therefore, most of the requested information regarding acceptance criteria, study sample sizes, expert involvement, and ground truth establishment is not present in this type of submission.
Here's what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not define specific performance acceptance criteria for the VARIOeco abutment in the way a clinical trial or performance study would. Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices. The "performance" assessment is primarily a comparison of intended use, technological characteristics, and materials to established devices.
| Feature/Characteristic | Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (VARIOeco) |
|---|---|---|
| Intended Use | Must be the same as or very similar to predicate devices. | "Thommen VARIOeco dental implant abutments are intended to be used in conjunction with Thommen System dental implants in the maxillary and/or mandibular arch to provide support for crowns, bridges and overdentures." (Same as predicates) |
| Operating Principle | Must be the same as predicate devices. | "uses the same operating principle" (as predicates) |
| Basic Design | Must be the same as predicate devices. | "incorporates the same basic design" (as predicates) |
| Materials | Must be the same or very similar to predicate devices. | Abutment: CPTi Gr 4; Burn-out sleeve: POM (Same or very similar to predicates) |
| Physical Dimensions | Must encompass the same range as predicate devices. | Platform diameters: 3.5, 4.0, 4.5, 5.0, 6.0 mm (Encompasses same range as or similar to predicates in overall scope) |
| Packaging & Sterilization | Must be similar to predicate devices. | "similar packaging and is sterilized using the same materials and processes" (as predicates) |
2. Sample Size for Test Set and Data Provenance
Not applicable. This is a 510(k) premarket notification for demonstrating substantial equivalence based on a comparison of device characteristics, not a study involving a test set of data or human subjects.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth as typically understood in a study context (e.g., for diagnostic accuracy) is not established in this type of submission. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate devices.
4. Adjudication Method for the Test Set
Not applicable. There is no test set in the context of a performance study to adjudicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is a dental implant abutment, and its approval process does not typically involve such studies.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
No, a standalone performance study in the context of an algorithm or AI is not applicable. This is a physical medical device.
7. Type of Ground Truth Used
The "ground truth" in this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The U.S. FDA's substantial equivalence determination means that the new device (VARIOeco) is as safe and effective as a legally marketed device (predicate device).
8. Sample Size for the Training Set
Not applicable. There is no "training set" as this is not a machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.)