(174 days)
Dentium Implantium® & SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation.
Dentium Implantium® / SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation. They consist of Dual Milling Abutment, Dual Abutment, Angled Abutment, Temporary Abutment, Direct-Casting Abutment and Metal Casting Abutment.
They are supplied non-sterile and sterilized by the recommended sterilization method in user's manual.
The materials of the Implantium & SuperLine Prosthetics are as follows; Pure Titanium Grade 4: Dual Milling Abutment, Dual Abutment, Angled Abutment and Temporary Abutment.
Co-Cr-Mo alloy (conform to ASTM F799) and Polyacetal (POM): Metal Casting Abutment,
Gold Alloy and Polyacetal (POM): Direct Casting Abutment.
This document is a 510(k) premarket notification for a dental prosthetic device, not an AI software. Therefore, the requested information about acceptance criteria, study design referencing AI/ML performance, and related ground truth establishment methods is not present in the provided text.
Specifically, the document focuses on demonstrating substantial equivalence of the Dentium Implantium® & SuperLine® Prosthetics to legally marketed predicate devices based on:
- Indications for Use: The devices are intended as an aid in prosthetic rehabilitation, matching the predicate devices.
- Design and Materials: Similarities in materials (Pure Titanium Grade 4, Co-Cr-Mo alloy, Gold Alloy, Polyacetal) and general shapes are emphasized. Minor differences in dimensions (total length, diameter, hex height) are noted but deemed not to affect application.
- Performance Bench Testing: Biocompatibility testing (ISO 10993-1) and mechanical performance testing (ISO Static compressive, ISO Fatigue, Corrosion Testing, Adaptation Accuracy) are reported.
- Non-clinical Testing: This includes "Reliability Calculation and Testing," "Fatigue Strength Testing," and "Static Load Failure Testing" in accordance with FDA guidance for dental implants/abutments.
The provided text does not contain:
- Any mention of acceptance criteria or performance metrics related to an AI/ML algorithm (e.g., sensitivity, specificity, AUC).
- Details on a test set's sample size for an AI/ML model, its provenance, or how ground truth was established by experts.
- Information on Multi-Reader Multi-Case (MRMC) studies or human-in-the-loop performance with AI assistance.
- Details about training sets for an AI/ML model.
Therefore, I cannot provide the requested table or study details specific to AI/ML device performance. The information in the document pertains to the physical and material characteristics and safety/performance of a traditional medical device (dental prosthetics).
§ 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.)