(14 days)
The Thommen SPI® EASY Dental Implant Protective Cap is intended to be used in conjunction with SPI® System dental implants, which provide support for crowns, bridges or overdentures in the maxillary and/or mandibular arch.
The Thommen SPI® EASY Dental Implant Protective Cap is an endosseous dental implant component made from polyetheretherketone (PEEK). The Protective Cap may be used for maintaining the gingival contour, replacing or augmenting the use of the Gingiva Former. If it is used to augment the function of the Gingiva Former, it is placed after the Gingiva Former is removed and the abutment is placed, but before the final restoration is placed. The Protective Cap also serves to protect the coronal aspect of the abutment from damage and the patient's tongue from injury during the time the final restoration is being fabricated.
The Protective Cap will be offered in sizes to fitall SPI® EASY abutments and may be used with all SPI® System dental implants.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document describes a 510(k) premarket notification for a dental implant component, focusing on its substantial equivalence to a predicate device. It details administrative information, device description, intended use, and equivalence to a marketed product, but it does not include any performance metrics, study designs, or acceptance criteria relevant to the questions asked.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or comparative effectiveness studies.
§ 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.)