Search Results
Found 1 results
510(k) Data Aggregation
(87 days)
Light Cure Dental Adhesive can be used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures:
- Direct bonding under a light-cured composite or compomer fillings/resin modified glass ionomer restoratives;
- Repair of dental restorations of ceramic, composites and/or metal alloys;
- Indirect dental restoration applications in combination with resin cement for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, mental-ceramic and/or porcelain, composites, and their combinations.
Light Cure Dental Adhesive is a universal self-etch visible light curable dentine bonding agent specifically designed for meeting all your bonding needs. It is not only for direct bonding under a dental composite restorative or a resin modified glass ionomer cement restorative, but also for all indirect dental restoration applications, either used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures. In all of those cases, this dental bonding agent will give you exceptional results and predicting a reliable treatment outcome.
This document is a 510(k) summary for a Light Cure Dental Adhesive, which is a medical device. This type of submission is for establishing substantial equivalence to a predicate device, not for a clinical AI/ML study. Therefore, the questions related to AI/ML device performance, such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details, are not applicable to this document.
However, I can extract the relevant information regarding the device's acceptance criteria and the studies performed to demonstrate its performance and substantial equivalence to a predicate device.
Acceptance Criteria and Device Performance for Light Cure Dental Adhesive (K201787)
This 510(k) submission establishes substantial equivalence for the Light Cure Dental Adhesive to a predicate device (DREAMBOND, K112118). The device is a dental bonding agent used in various dental restorative procedures.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance (Light Cure Dental Adhesive) |
|---|---|---|
| Physical Properties | ISO 29022:2013 (Dentistry - Adhesive - Notched-edge sheer bond strength test) | Conforms to specifications of ISO 29022:2013 and internal final inspection standard. Substiantially equivalent physical property of shear bond strength to predicate device. |
| Biocompatibility | ISO 10993 standards (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Subchronic Toxicity, Genotoxicity) | Performed fully following ISO 10993 standards and passed all tests. |
| Technological Characteristics | Similar method of polymerization, resin composition, solvent, method of application, prescription use, and etch method to predicate. Indications for Use are similar and fall within the intended use of the predicate device. | All evaluated technological characteristics (Method of polymerization, Resin composition, Solvent, Method of application, Indications of Use, Prescription/over-the-counter use, Etch Method) are either identical or substantially equivalent to the predicate device. |
Summary of Studies that Prove the Device Meets Acceptance Criteria:
The device's performance and meeting of acceptance criteria were demonstrated through non-clinical testing, primarily focused on physical/chemical properties and biocompatibility.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated as a numerical 'sample size' in the context of clinical data for AI/ML. For physical/chemical and biocompatibility testing, standard laboratory samples would have been used as per ISO guidelines, but specific numbers are not provided in this summary.
- Data Provenance: The studies were conducted by Rizhao HuGe Biomaterials Company, Ltd. (China) and its contracted laboratories. The tests are non-clinical, laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a non-clinical submission. Ground truth, in this context, refers to scientific and regulatory standards (ISO standards) rather than expert clinical evaluation of an algorithm's output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This pertains to clinical evaluation or human-in-the-loop performance, which is not part of this 510(k) submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. No MRMC study was conducted as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for demonstrating substantial equivalence was based on internationally recognized testing standards (ISO 29022:2013 for physical properties and ISO 10993 for biocompatibility) and comparison to the technological characteristics and established safety/effectiveness of the legally marketed predicate device.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device.
Ask a specific question about this device
Page 1 of 1