(283 days)
Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the healing phase. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Strauman® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
There are three components to the Straumann® SC Variobase® Abutments:
- Straumann® SC Variobase® Abutments (Ti-base)
- Prosthetic restoration (coping and/or crown)
- Basal Screw
The Straumann® SC Variobase® Abutments are manufactured from TAN. The abutments are oval in shape to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The abutments will be delivered with the corresponding basal screw.
The prosthetic restoration (the second component of the two-piece abutment) is digitally designed using CAD software and sent to Straumann for manufacture at a validated milling center.
The purpose of this submission is to add the following materials to the previously cleared list of top-half materials for use on the previously cleared Straumann® SC Variobase® Abutments: - Digital materials:
- zerion ML
- zerion UTML
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental implant abutment, discussing its equivalence to predicate devices, indications for use, and a summary of performance testing related to sterilization, biocompatibility, and bench testing (dynamic fatigue and static strength).
It does not describe the acceptance criteria and study proving a device meets acceptance criteria in the context of an AI/ML medical device. Specifically, it lacks:
- A table of acceptance criteria and reported device performance for an AI/ML device (e.g., sensitivity, specificity, AUC).
- Sample sizes for AI/ML test sets, data provenance, ground truth establishment methods, or details about expert reviewers.
- Information regarding MRMC studies or human reader improvement with AI assistance.
- Details on standalone algorithm performance.
- Sample sizes or ground truth establishment for an AI/ML training set.
Therefore, I cannot fulfill your request based on the provided input.
§ 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.)