(91 days)
Dual Cure Resin Cement is a dental luting system designed 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, metal-ceramic, all-ceramic and/or porcelain, composites, and their combinations.
Dual Cure Resin Cement is a versatile and ultimate dental dual cure (chemical and/or light cure) luting cement. This multi-purpose device is designed for cementation of all sorts of dental restorations made from materials of metal-ceramic, all-ceramic and/or porcelain, composites, and their combinations.
Dual Cure Resin Cement contains paste-paste of Base and Catalyst comprising primarily of dental methacrylate resins and inorganic fillers (with particle size range from about 0.01 - 3 microns and a filler volume of about 40%), inorganic pigments, photo-initiation and chemical curing systems. The mixing ratio, based on volume, is 1 part base paste : 1 part catalyst paste.
Dual Cure Resin Cement is delivered in either two seperated single syringe for Hand-mix and double-barrel syringes for Automix and comes in seven shades: TR (Translucent), A0 (Light+), A 1 (Light), A2 (Medium), A3 (Dark), White (White Opaque) and Opaque (Universal Opaque).
Dual Cure Resin Cement is radiopaque, allowing for easy identification on radiographs.
The provided document is a 510(k) summary for a dental device, "Dual Cure Resin Cement." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies as might be required for a PMA (Premarket Approval) submission.
Therefore, many of the typical acceptance criteria and study details requested (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details) are generally not applicable in this context. The acceptance criteria in this document relate to physical and chemical properties and comparison to a predicate device.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO standards) | Reported Device Performance | Conclusion |
|---|---|---|
| Film thickness of luting materials ≤ 50 µm (ISO 4049:2009, 5.2.2) | Satisfactory | Pass |
| Working time ≥ 60 s (ISO 4049:2009, 5.2.4) | Satisfactory | Pass |
| Setting time ≤ 10 min (ISO 4049:2009, 5.2.6) | Satisfactory | Pass |
| Flexural strength ≥ 50 MPa (ISO 4049:2009, 5.2.9) | Satisfactory | Pass |
| Water sorption ≤ 40 µg/mm³ (ISO 4049:2009, 5.2.10) | Satisfactory | Pass |
| Solubility ≤ 7.5 µg/mm³ (ISO 4049:2009, 5.2.10) | Satisfactory | Pass |
| Radio-opacity ≥ 1 mm of aluminum (ISO 4049:2009, 5.5) | Satisfactory | Pass |
| Shear bond strength for enamel and dentin ≥ 8 MPa (Internal standard, comparable to ISO 29022:2013) | Satisfactory | Pass |
| Biocompatibility (following ISO 10993 for Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Subchronic Toxicity and Genotoxicity) | Satisfactory | Pass |
2. Sample size used for the test set and the data provenance
The document specifies "tests were performed fully following the ISO 10993 standards" for biocompatibility and specific ISO standards for physical and chemical properties (ISO 4049:2009 and ISO 29022:2013). However, it does not provide details on the specific sample sizes used for each of these tests.
Regarding data provenance, the testing was conducted by Rizhao HuGe Biomaterials Company, Ltd. There is no explicit mention of data provenance (e.g., country of origin, retrospective/prospective) for these lab-based material property tests, as they are typically conducted under controlled laboratory conditions, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a dental cement, and its performance is evaluated based on objective physical, chemical, and biological properties according to international standards (ISO). There is no "ground truth" established by human experts in the way that, for example, a diagnostic AI device would use expert interpretations of medical images. The "ground truth" here is derived from the standardized test methods and their defined pass/fail criteria.
4. Adjudication method for the test set
Not applicable. As the "ground truth" is determined by standardized laboratory measurements against defined criteria, no human adjudication method (like 2+1 or 3+1 consensus) is relevant for this type of device testing.
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. This is a dental cement, not a diagnostic imaging device or an AI-assisted device. Therefore, MRMC studies and AI assistance comparisons are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a dental cement, not an algorithm or AI-based device.
7. The type of ground truth used
The ground truth for this device is based on objective, standardized laboratory measurements of physical, chemical, and biological properties, as defined by international standards (ISO 4049:2009, ISO 29022:2013, and ISO 10993 series). The criteria are specific numerical values or qualitative outcomes (e.g., "Satisfactory").
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set. The performance is based on the inherent material properties of the cement.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for this type of device, this question is not relevant.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.