(137 days)
FRIADENT® EsthetiCap is an anatomically shaped abutment used for fabrication of screw-retained or cementable temporary crowns or bridges. The FRIADENT® EsthetiCap is a short-term provisional abutment for esthetic shaping of soft tissue.
The FRIADENT® EsthetiCap abutments create anatomic, esthetic peri-implant gingival contours by simple customization. FRIADENT® EsthetiCap abutments are available in five diameters (3.4 mm - 6.5 mm) and two shapes (oval and triangular) that reproduce the crosssection of the tooth at the cementum-enamel junction (CEJ).
The provided text describes a 510(k) premarket notification for a dental device, the FRIADENT® EsthetiCap. However, it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The document is a regulatory submission for substantial equivalence based on comparison to predicate devices, not a study reporting performance metrics or clinical outcomes. It focuses on device description, intended use, and technological characteristics compared to previously cleared devices.
Therefore, I cannot provide the requested information from the given 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.)