(358 days)
BioHPP polymer is used for the fabrication of definitive crown and bridge frameworks with no more than 2 pontics and for definitive removable restorations. BioHPP can also be used for fully anatomical pressed bridge structures - with or without buccal composite veneering.
- · Fully anatomical crowns and bridges (max. 2 pontics)
- · Crown copings and bridge substructures for composite veneers (max. 2 pontics)
- · Telescopic primary and secondary crowns and frameworks
• Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide
breCAM.BioHPP is used for the fabrication of permanent restorations using CAD/CAM techniques.
Fully anatomical crowns and bridges (max. 2 pontics and min. 13 mm² connector crosssection)
Crown copings and bridge substructures for composite veneering (max. 2 pontics and min. 13 mm² connector cross-section))
Telescopic primary and secondary crowns and frameworks Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide. Reference is made to the instructions for use "BioHPP elegance prefab for SKY" to fabricate an individual abutment.
BioHPP is a tooth-colored thermoplastic high-performance polymer based on polyether ether ketone (PEEK), which was developed especially for the fabrication of dental restorations. Bio HPP is available in two different variations - as a granular material and prefabricated cylinders with diameters of 15 mm and 25 mm (so-called pellets).
breCAM.BioHPP is based on filled polyether ether ketone (PEEK) and used for the fabrication of permanent crowns and bridges using CAD/CAM techniques. Three sizes are available.
This document is a 510(k) Pre-Market Notification from the FDA regarding the dental material BioHPP and breCAM.BioHPP. It is a regulatory approval document and not a scientific study report. Therefore, it does not contain the information requested about acceptance criteria and a study proving device performance as it pertains to AI/ML devices.
The questions refer to the validation of an AI/ML device, which involves concepts like:
- Acceptance Criteria for AI/ML performance (e.g., sensitivity, specificity, AUC): Not applicable to a dental material's physical properties.
- Sample Size for Test Set and Data Provenance: Not applicable. The document refers to physical property testing, not data sets for AI.
- Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth for an AI model's output (e.g., image annotation) is not relevant for evaluating the mechanical properties of a dental material.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Study: Not applicable. This is for evaluating human performance with and without AI assistance.
- Standalone Performance: Not applicable.
- Type of Ground Truth (Expert Consensus, Pathology, Outcomes Data): Not applicable. The "ground truth" here would be the actual physical properties measured in a lab, not expert interpretations of data.
- Sample Size for Training Set, and How Ground Truth for Training Set was Established: These are concepts for machine learning models and are not present or relevant in this document about a dental material.
Therefore, I cannot provide the requested information based on the provided text because the document describes the regulatory approval of a dental material based on its physical and mechanical properties, not the validation of an AI/ML device.
The tables in the document compare the physical characteristics (e.g., water absorption, flexural strength, density) of the new device (BioHPP and breCAM.BioHPP) against predicate devices. These are material properties, not performance metrics of an AI algorithm.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.