(84 days)
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.
The purpose of this submission is to expand the Neodent Implant System components cleared under K101945 and K123022. This submission includes Facility Universal Post and Equator Attachment CM abutments with a Morse taper interface. Facility Universal Post abutments are straight, post-type abutments for cemented prosthetic restorations. They are provided in one platform diameter (3.3 mm), gingival heights of 1 mm to 5 mm, and prosthetic heights of 4 mm and 6 mm. Facility Universal Post abutments are compatible with the Facility dental implants cleared in K123022, and with the Universal Post Cylinders cleared in K101945. Equator Attachment CM abutments are straight, ball-type abutments for the attachment of overdentures or partial dentures. They are provided in five gingival heights (1.5, 2.5, 4.5 and 5.5 mm). These abutments have a titanium nitride (TiN) coating for the purpose of creating a harder surface to increase wear resistance. This titanium nitride coating is identical to that used on the Neodent CM Mini Ball Attachment cleared in K101945, and the Facility Equator Attachment cleared in K123022. Equator Attachment CM abutments are compatible with Titamax CM, Titamax CM EX, and Alvim CM implants cleared in K101945, and with the CM Drive implants cleared in K123022. All abutments in this submission are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
The provided text is a 510(k) Summary for the Neodent Implant System. It outlines the device description, its intended use, and its equivalence to previously marketed predicate devices.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone) related to the Neodent Implant System.
The 510(k) summary explicitly states: "Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility, engineering analysis and dimensional analysis. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. Clinical data were not submitted in this premarket notification."
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical data, rather than presenting a performance study with acceptance criteria.
§ 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.)