(294 days)
Inclusive® Zirconia Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Inclusive® Zirconia Abutments are compatible with the following bone-level implants:
- Biomet 3i™ Certain® internal hex implants with 3.4, 4.1, 5.0, 6.0 mm platform diameters
- Nobel Biocare NobelReplace® straight and tapered internal connection implants with NP, RP, WP, 6.0 mm platform diameters
- Zimmer Dental Screw-Vent® and Tapered Screw-Vent® internal hex implants with 3.5, 4.5, 5.7 mm platform diameters (excluding 3.3 mmD Screw-Vent implants)
Inclusive Zirconia Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is fastened into the implant with a screw.
The purpose of this 510(k) filing is to validate our inclusive abutment screw to be used with our Inclusive® Zirconia Abutments that are compatible with the following bone-level implants:
- Biomet 3i™ Certain® internal hex implants with 3.4, 4.1, 5.0, 6.0 mm platform diameters
- Nobel Biocare NobelReplace® straight and tapered internal connection implants with NP, RP, WP, 6.0 mm platform diameters
- Zimmer Dental Screw-Vent® and Tapered Screw-Vent® internal hex implants with 3.5, 4.5, 5.7 mm platform diameters (excluding 3.3 mmD Screw-Vent implants)
The predicate device utilizes an OEM abutment screw vs. the inclusive abutment screw used by the proposed device.
The provided document is a 510(k) Pre-market Notification for Inclusive® Zirconia Abutments. This document describes the device and its claimed substantial equivalence to a predicate device, focusing on non-clinical testing. It does not include information on acceptance criteria for a study proving device performance in the context of an Artificial Intelligence (AI) / Machine Learning (ML) enabled medical device.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study or related effect size.
- Standalone performance (algorithm only).
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document pertains to a traditional medical device (dental abutments) and its regulatory clearance through a substantial equivalence pathway, primarily supported by bench testing (fatigue and static load failure testing) in accordance with relevant FDA guidance and ISO standards. It does not involve AI/ML components or associated studies for diagnostic or prognostic performance.
§ 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.)