(209 days)
The Strauman® PURE Ceramic Implant is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw.
The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.
The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.
The Straumann® PURE Ceramic Implants (Tissue Level Monotype and Tissue Level two-piece design) are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding instruments and prosthetic parts. The Straumann® PURE Ceramic Implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched (ZLA® surface). The implants have a 1.8 mm high machined transmucosal neck. The Straumann® PURE Ceramic Implant has a two -piece design with internal connection based on features of the Straumann® Tissue Level Standard Plus and Straumann® Bone Level Implants. The Straumann® PURE Ceramic Implant Monotype features a monotype design where the ceramic abutment for final restoration is already built in.
This document, a 510(k) summary for the Straumann® PURE Ceramic Implants, does not contain information about an AI/ML device or a study proving its performance against acceptance criteria in the way a typical AI/ML medical device submission would.
The document describes a dental implant (a physical medical device) and its equivalence to previously cleared predicates. The nonclinical testing mentioned (dynamic fatigue, biological assessment, sterilization validation, packaging stability, MRI compatibility, surface features) are standard tests for physical implants to ensure their safety and effectiveness.
Therefore, I cannot extract the requested information regarding acceptance criteria and study data for an AI/ML device from this document. The concepts of "test set," "ground truth experts," "adjudication," "MRMC study," "standalone performance," "training set," and "how ground truth for training set was established" are not applicable to the non-AI/ML device described in this 510(k) summary.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.