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510(k) Data Aggregation
(431 days)
BB Base 3D printing resin for denture base, developed by ENLIGHTEN MATERIALS Co., Ltd., is a light-cured resin indicated for the fabrication of full removable denture bases in dental laboratories. It is an alternative to traditional heat-cured, light-cured or light-cured denture base resins. BB Base 3D printing resin for denture base should be used exclusively by dental professionals. Fabrication of denture bases with BB Base 3D printing resin for denture base requires a computer-aided and manufacturing (CAD/CAM) system including the following; optical impression system, design software (CAD software), stereolithographic additive printer, and post-cure unit.
BB Base is a photosensitive resin intended to fabricate removable dentures in a CAD/CAM additive printing process. The BB Base 3D printing resin for denture base is a viscous solution of the following compounds: methacrylate-based resins, a photoinitiator that activates between 385nm to 405 nm light, and pigments. It comes in one size, one kilogram per bottle. It is a Type 4 (light-activated) acrylic resin as classified ISO20795-1. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. After printing, the printed product is placed in a UV-light curing box for final polymerization. 3D printer is not included with the device.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
Device Name: BB Base 3D printing resin for denture base
Predicate Device: Dentca Denture Base II (K162044)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are largely based on the ISO 20795-1 standard for "Dentistry - Base polymers - Part 1: Denture base polymers" and comparisons to the predicate device.
| Performance Metric | Acceptance Criteria (ISO 20795-1 where applicable) | Reported Device Performance (BB Base) | Comparison to Predicate (Dentca Denture Base II) |
|---|---|---|---|
| Material Properties | |||
| Flexural Strength | > 65 MPa (Predicate's value, implied as threshold) | > 85.2 MPa | Met the criteria of ISO 20975-1 |
| Flexural Modulus | > 2000 MPa (Predicate's value, implied as threshold) | > 2049 MPa | Met the criteria of ISO 20975-1 |
| Viscosity | 1000 < x < 2000 cps (Predicate's value) | ~ 1180 cps | Met the criteria of ISO 20975-1 |
| Cytotoxicity | Biocompatible (based on ISO 10993-5) | Addressed/Compliant | Not directly compared, but both aim for biocompatibility |
| Sensitization | Biocompatible (based on ISO 10993-10) | Addressed/Compliant | Not directly compared |
| Irritation/Intracutaneous Reactivity | Biocompatible (based on ISO 10993-10) | Addressed/Compliant | Not directly compared |
| Acute Systemic Toxicity | Biocompatible (based on ISO 10993-11) | Addressed/Compliant | Not directly compared |
| Genotoxicity | Biocompatible (based on ISO 10993-3) | Addressed/Compliant | Not directly compared |
| Residual Monomer | Compliant with ISO 20795-1 requirements | Tested, presumed compliant | Not directly specified for predicate |
| Water Sorption | Compliant with ISO 20795-1 requirements | Tested, presumed compliant | Not directly specified for predicate |
| Water Solubility | Compliant with ISO 20795-1 requirements | Tested, presumed compliant | Not directly specified for predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the non-clinical performance tests (e.g., how many samples were tested for flexural strength, viscosity, etc.).
The data provenance is from non-clinical performance testing conducted by the manufacturer, Enlighten Materials Co., Ltd. The country of origin of the data is not explicitly stated, but the company's address is in Taiwan. The data is retrospective in the sense that it was generated for the 510(k) submission, not as part of an ongoing clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the studies described are non-clinical (bench testing of material properties and biocompatibility). There is no "ground truth" in the clinical sense established by human experts for this type of testing. The "ground truth" here is the adherence to defined material standards (ISO).
4. Adjudication Method for the Test Set
This section is not applicable for non-clinical bench testing. Adjudication methods are typically relevant for clinical studies where multiple human readers or experts assess outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "We did not conduct clinical performance testing for this submission device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a 3D printing resin, not an algorithm or an AI-powered system that would have "standalone" performance in the context of human-in-the-loop. The "performance" here refers to the physical and biological properties of the material.
7. The Type of Ground Truth Used for the Test Set
The "ground truth" for the non-clinical test set is based on:
- International Standards: Primarily ISO 20795-1 for mechanical properties and ISO 10993 series for biocompatibility.
- Predicate Device Performance: The predicate device's established performance values (e.g., for flexural strength, flexural modulus, viscosity) also serve as a benchmark for substantial equivalence comparisons.
8. The Sample Size for the Training Set
This section is not applicable. As a physical material (3D printing resin), there is no "training set" in the context of AI/ML algorithms. The product's properties are inherent to its formulation and manufacturing process, evaluated through bench tests.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the reasons stated in point 8.
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