(84 days)
Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.
Fabrication of dental prosthetics with Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment.
The Denture Base consists of a curable dental acrylate resin that is designed to be used in conjunction with a scanned 3D image of a patient's teeth, and 3D printer assembly, to locally manufacture out a dental appliance in dental offices based on the clinician's judgment of patient need.
Denture Base resin is intended exclusively for professional dental work.
Denture Base is designed to meet appropriate ISO standards for flexibility, sorption, and solubility to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.
I am sorry, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter and summary for a denture base resin, focusing on the substantial equivalence to a predicate device through biocompatibility and bench testing.
Specifically, the document does not describe acceptance criteria for a study, nor does it detail a study that proves a device meets such criteria in the way you've outlined for AI/software-based medical devices.
The document describes material testing for a physical product (denture resin), not the performance of an algorithm or AI model. Therefore, information such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, and how training ground truth was established, are not present.
The "performance data" mentioned in the document refers to:
- Biocompatibility Testing: According to ISO 10993-1, covering tests like Cytotoxicity, Genotoxicity, Acute Systemic Toxicity, Subchronic toxicity, Irritation, and Sensitization.
- Bench Testing: According to ISO 20795-1, covering tests like Ultimate Flexural Strength and Modulus, Water Sorption and Solubility, Residual Methyl Methacrylate Monomers, Homogeneity, Surface Characteristics, Shape Capability, Translucency, Polishability, Colour, Freedom from Porosity, Color Stability, Maximum stress intensity factor, Total fracture work, and Bonding to synthetic polymer teeth.
These are tests of the physical properties and biological safety of the material, not algorithmic performance.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.