(181 days)
The Inclusive Abutment is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
The Inclusive Abutment for Zimmer Implant is compatible with Zimmer Screw Vent and Tapered Screw Vent internal hex implants. The Inclusive Abutment for 3i Implant is compatible with 3i Certain internal hex implants. The Inclusive Abutment for Nobel Biocare Implant is compatible with Nobel Biocare Replace straight and tapered internalconnection implants.
Please note: This device may be used in an early load situation, dependent on the specific implant system and protocol used by the dental professional; and, highly angled abutments (i.e. 20 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.
The device is comprised of titanium alloys. The device is designed to be screw-retained for use with Endosseous dental implants as an aid in prosthetic rehabilitation.
The provided 510(k) summary does not contain information about acceptance criteria or a study proving the device meets said criteria in the way typically associated with AI/ML-driven medical devices.
This documentation describes a dental implant abutment (Inclusive™ Implant Abutment), which is a physical device, not a software algorithm or an AI-based system. Therefore, the standard elements of an AI/ML device study (like test sets, ground truth, expert adjudication, MRMC studies, standalone performance, training sets, etc.) are not relevant and are not present in this submission.
Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This is a common pathway for physical medical devices where the innovation is incremental.
Here's a breakdown of why the requested information is not applicable and what the document does provide:
- 1. A table of acceptance criteria and the reported device performance: Not applicable. There are no specific performance metrics like sensitivity, specificity, AUC, or F1-score for this type of physical device. The "performance" is implicitly deemed acceptable if it functions similarly to predicate devices.
- 2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML study.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth establishment for a physical dental abutment.
- 4. Adjudication method: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
What the submission focuses on instead:
- Description: The device is made of titanium alloys and is screw-retained for use with endosseous dental implants.
- Intended Use: To be used by dental technicians in the construction of custom-made dental restorations supported by implants.
- Substantial Equivalence: The primary proof of safety and efficacy relies on its similarity to other legally marketed devices (3i, Nobel Biocare, Zimmer abutments). The submission states, "The device functions in a similar manner to other comparative devices and the intended use is the same. The differences between comparative devices are minor and do not raise new safety concerns."
- Indications for Use: The abutment supports crowns, bridges, or overdenture prostheses, and is compatible with specific Zimmer, 3i, and Nobel Biocare internal hex and internal connection implants. It also includes specific warnings regarding early load situations and highly angled abutments.
In summary, this 510(k) pertains to a traditional medical device, not an AI/ML device. Therefore, the questions about acceptance criteria and studies are not relevant in the context of this document.
§ 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.)