(361 days)
The SFI-Anchor® D20 is intended for the fixation of (dental) prostheses to corresponding dental implants. The compatible implant systems are specified in Table 1 below. The SFI-Anchor® CD20 is intended as an additional retaining element on CAD / CAM milled dental bars.
The SFI-Anchor® D20 is an endosseous dental implant abutment for the fixation of (dental) prostheses to the following ITI Dental Implant System® / Straumann® Dental Implant Systems: Standard Ø 4.1 mm Regular Neck (RN) / Standard Ø 4.8 mm Regular Neck (RN) / Standard Plus Ø 4.1 mm Regular Neck (RN) / Standard Plus Ø 4.8 mm Regular Neck (RN) / Tapered Effect Ø 4.1 mm Regular Neck (RN) / Bone Level Ø 4.1 mm, Regular CrossFit® (RC) / Bone Level Ø 4.8 mm, Regular CrossFit® (RC). The SFI-Anchor® CD 20 is intended as an additional retaining element on dental bars. The SFI-Anchor® D20 are straight abutments with gingival heights ranging from 1mm to 5 mm. The SFI-Anchor® CD 20 is a straight bar attachment. The SFI-Anchor® Housing and the SFI-Anchor® Retention Inserts can correct for up to 10° of divergence (20° of divergence between two implants). The SFI-Anchor® is offered in a diameter 4.8 mm. The SFI-Anchor® D20 is connected to the corresponding implants via a mating screw thread and interface geometry. The SFI-Anchor® CD20 is directly screwed on a dental bar construct. The SFI-Anchor® Housing is cemented in the dental prostheses. The SFI-Anchor® Housing, along with an SFI-Anchor® Retention Insert, allow connection of the prosthesis to the abutment / bar attachment by retention-grip. The abutments / bar attachment are machined from Titanium Alloy conforming to ASTM F-136. Other SFI-Anchor® key functional parts are made out of Elitor® (conforming to standard ISO 22674) and of Pekkton® conforming to standard ASTM D3418, ASTM D638 and ASTM D790.
The provided text describes a dental implant abutment, SFI-Anchor® D20 and SFI-Anchor® CD20, and its substantial equivalence to predicate devices. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.
Therefore, I cannot provide the requested information. The document focuses on the mechanical and material characteristics of the dental abutments, their compatibility with implant systems, and a comparison with existing predicate devices to establish substantial equivalence for regulatory approval. It is not an AI/ML device.
§ 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.)