(149 days)
The Custom Abutment Ti with Screw is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments Ti with Screw are indicated for screw-retained single restorations or cemented-retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Screw are intended to be sent to Straumann for manufacturing at a validated milling center.
The Custom Abutment with Angled Screw Channel is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations. All abutments are only intended to be digitally designed and manufactured using specifics CAD/CAM software according to digital dentistry workflow. Custom Abutments with Angled Screw Channel are indicated for screw-retained single restorations or cemented-retained single or multiple restorations. All digitally designed abutments for use with the Custom Abutment Ti with Angled Screw Channel are intended to be sent to Straumann for manufacturing at a validated milling center.
The Custom Abutments subject to this submission are similar to the devices already cleared in previous Neodent and Nuvo Implant System submissions, per the predicate and reference devices described above. This submission intends to expand the portfolio of digital abutments for the Grand Morse (GM), Narrow Grand Morse (NGM) and Helix Short (HS) lines, to provide more treatment options for customers. These abutments are composed of a unique body with two regions: the upper region is the customized portion, while the end region presents the prosthetic interface that fits with the implant, which does not allow customization.
They are intended for single use and provided non-sterilization recommended before installation in the mouth.
All proposed abutments are delivered to the final user already customized in a validated milling center, with a straight channel solution. For the GM line, the abutments could also be milled with a new angled channel solution for the screw access. All subject devices must be used with their corresponding prosthetic interface.
The provided text describes the Neodent Implant System - Custom Abutments, a medical device. This product is not an AI/ML device, and therefore does not have acceptance criteria or a study that proves the device meets those criteria in the way requested in the prompt.
The document discusses the substantial equivalence of the Neodent Implant System - Custom Abutments to legally marketed predicate devices, which is the basis for its 510(k) clearance by the FDA. The performance testing section describes bench tests (dynamic fatigue and torsion tests), sterilization validation, MR compatibility testing, and biocompatibility testing. These tests evaluate the physical, chemical, and biological properties of the device, comparing them to established standards and predicate devices to demonstrate equivalence, not to meet a set of acceptance criteria for an AI/ML algorithm's performance.
Because the device is not an AI/ML device, the specific information requested about acceptance criteria for AI performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and how ground truth for training was established is not applicable and is not present in the provided text.
§ 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.)