(90 days)
The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann implants.
The Straumann® Retentive System (to which PUREloc belongs) is designed for the use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. The Straumann® Retentive System consists of abutments which are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. They are available in different sizes and angles to fit individual patient needs. Straumann® PUREloc abutments are used exclusively on the Straumann PURE Ceramic Implants, are available in 6 heights (1 mm, 2 mm, 3 mm, 4 mm, 5 mm, and 6 mm) and made of Yttrium-stabilized zirconia ceramic (ISO 13356 - Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)). The Straumann® PUREloc abutments are non-engaging and the implant-to-abutment connection is provided for by the basal screw. The basal screw is manufactured from Titanium Grade 4 and is identical to the basal screw cleared under K180477.
This is a 510(k) premarket notification for the Straumann® PUREloc abutments. It describes the device, its intended use, and compares its technological characteristics to predicate and reference devices. However, this document does not contain acceptance criteria for an AI/ML device or a study demonstrating the device meets such criteria.
The information provided in this document pertains to traditional medical device clearance, focusing on:
- Substantial Equivalence: Comparing the proposed device to legally marketed predicate devices.
- Performance Testing: Bench testing (dynamic fatigue, snapping force, dynamic force), sterilization validation, and biocompatibility evaluations.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, ground truth details, MRMC study, or standalone algorithm performance) related to an AI/ML device from this document. The document describes criteria for dental implant abutments, not an AI/ML system.
§ 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.)