(272 days)
Dentca Denture Base is a light-cured resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-cured and auto polymerizing resins.
Fabrication of dental prosthetics with Dentca Denture Base requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, stereolithographic additive printer, and curing light equipment.
Dentca Denture Base is a photosensitive resin intended to fabricate removable dentures in a CAD/CAM additive printing process.
The Dentca polymer is a viscous solution of the following compounds: methacrylate-based resins, a photoinitiator that activates at 405 nm visible (blue) light, an inhibitor, and pigments. It comes in two sizes, large and small bottles (see photo at right). It is a Type 4 (lightactivated) acrylic resin as classified by ANSI/ADA Specification No. 12.
The denture fabrication process begins with a traditional casting impression of the oral region in the dentist office. This impression is sent to a dental lab for conversion to digital image in an optical impression system. The denture base is then made layer-by-layer in a stereolithographic laser printer. After attachment of preformed plastic teeth, the denture is cured in a light chamber, and, lastly, sent back to the dentist for try-in and final adjustment.
The provided text describes a submission for a dental device, "Dentca Denture Base," for FDA 510(k) clearance. This device is a photosensitive resin used in a CAD/CAM additive printing process to fabricate removable dentures. The key aspect of the submission, from a performance data perspective, is demonstrating that the new manufacturing method (3D printing) yields a product that is substantially equivalent to existing, manually fabricated denture bases.
Based on the provided text, here's a breakdown of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "Dentca Denture Base" are primarily based on established industry consensus standards for dental materials, specifically ISO 20795-1 (Dentistry - Base polymers - Part 1: Denture base polymers). While the document doesn't explicitly list "acceptance criteria" in a go/no-go format, it presents key performance specifications derived from this standard that the device was tested against.
| Acceptance Criterion (Implicit based on ISO 20795-1) | Reported Device Performance |
|---|---|
| Flexural strength | 90.2 MPa |
| Flexural modulus | 2,290 MPa |
| Residual monomer | Not detectable |
| Water sorption | 14 ug/mm3 |
| Water solubility | 1.3 ug/mm3 |
| Biocompatibility (Genotoxicity, Cytotoxicity, Sensitization, Irritation, Acute Toxicity, Material Characterization) | Conformed to FDA Blue Book Memorandum #G95-1 and ISO 10993-1 (Pass) |
Note: The document states "Dentca Denture Base was tested for conformity with the industry consensus standard ISO 20795-1," implying that the reported values meet or exceed the requirements of this standard for these properties.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the bench testing (flexural strength, modulus, water sorption, water solubility, residual monomer). It only mentions that these tests were conducted.
Regarding data provenance:
- The data is generated from bench testing of the Dentca Denture Base material.
- The origin of the data (country, specific lab) is not specified, but the applicant (Dentca, Inc.) is based in Los Angeles, CA, USA.
- The testing is inherently prospective as it involves manufacturing and testing samples of the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This submission is for a material (denture base resin), not an imaging or diagnostic device requiring expert interpretation of results. Therefore, the concept of "ground truth" established by experts in a concensus fashion (like for medical image analysis) is not applicable here. The ground truth for the material properties is established by the standardized measurement methods outlined in ISO 20795-1.
4. Adjudication Method for the Test Set
As this is bench testing of material properties against a standard, there is no adjudication method in the traditional sense (e.g., 2+1, 3+1). The "results" are quantitative measurements (e.g., 90.2 MPa for flexural strength) obtained through standardized laboratory procedures.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and effect size
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic or classification AI devices where human performance with and without AI assistance is being evaluated. This submission is for a dental material and its manufacturing process, not a diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not directly applicable as the device is a material, not a software algorithm. However, the performance metrics (flexural strength, modulus, etc.) are essentially "standalone" measurements of the material's physical properties. The device itself (the resin) performs its function (forming a denture base) independently of human "performance" in the analytical sense.
7. The Type of Ground Truth Used
The ground truth for the performance of the Dentca Denture Base is based on standardized, objective physical and chemical measurements as defined by ISO 20795-1. For biocompatibility, the ground truth is adherence to established biological safety standards (ISO 10993-1). This is not "expert concensus," "pathology," or "outcomes data" in the typical clinical study context for diagnostic devices.
8. The Sample Size for the Training Set
The concept of a "training set" is relevant for machine learning or AI models. This submission is for a physical material, not an AI model that learns from data. Therefore, there is no training set in this context. The manufacturing process is based on controlled chemical formulations and physical processes.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" for this material, this question is not applicable. The "ground truth" for the material's properties is derived from the scientific principles and established testing methodologies outlined in the ISO standards, ensuring the material meets the necessary performance and safety criteria for its intended use.
§ 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.