(49 days)
Pulpdent RMGI Low Viscosity is a resin-modified glass ionomer preparation used by dental professionals as a liner, base or luting material in dental restorations.
Pulpdent RMGI Low Viscosity is a resin-modified glass ionomer preparation with both a bioactive resin matrix and bioactive glass fillers. In this context, 'bioactive' refers to the release of beneficial ions from the resin and glass fillers into the oral environment. As a resin-modified glass ionomer, RMG/ Low Viscosity has three setting mechanisms: light cure, self-cure resin chemistry, and acid-base glass ionomer reaction. It contains no Bisphenol A, no Bis-GMA and no BPA derivatives. RMGI Low Viscosity is a paste-paste formulation provided in an automix syringe.
This looks like a 510(k) summary for a dental cement. The provided information is related to the performance of a medical device (dental material) and its comparison to predicate devices, rather than an AI/ML device that would typically involve acceptance criteria, various types of studies (MRMC, standalone), and ground truth establishment with expert consensus on a test set.
Therefore, many of the requested fields are not applicable in this context. However, I can extract the relevant information regarding the performance testing and comparison for the Pulpdent RMGI Low Viscosity dental cement.
Here's the breakdown based on the provided document:
Acceptance Criteria and Device Performance
The document doesn't explicitly state "acceptance criteria" in the format typically seen for a new AI/ML device seeking regulatory approval. Instead, it presents performance testing results for the device and compares them to predicate devices to demonstrate substantial equivalence. The implication is that meeting or exceeding the performance of existing legally marketed predicate devices demonstrates acceptability.
Table 1: Performance Testing Summary for Pulpdent RMGI Low Viscosity
| Property | Self-cure (Reported Performance) | Light cure (Reported Performance) |
|---|---|---|
| Flexural strength | 81.0 MPa | 88.0 MPa |
| Compressive strength | 208.0 MPa | 239 MPa |
| Flexural modulus | 3.7 GPa | Not tested |
| Diametral tensile strength | 38.0 MPa | 36.0 MPa |
| Working time | 2 min 30 seconds | Not applicable |
| Setting time | 3-3.5 min from beginning of mix | 20 seconds |
| Radiopacity | Equivalent to 2 mm aluminum | Equivalent to 2 mm aluminum |
Table 2: Comparison of Performance with Predicate Products
| Product | Compressive Strength (MPa) | Flexural Strength (MPa) | Flexural Modulus (GPa) | Diametral Tensile Strength (DTS) (MPa) |
|---|---|---|---|---|
| Pulpdent RMGI Low Viscosity (auto cure) | 208 | 81.0 | 3.7 | 38 |
| Pulpdent RMGI Low Viscosity (light cure) | 239 | 88.0 | - | 36 |
| Pulpdent Tuff Temp 2.0 | 205.0 | 84.0 | - | --- |
| 3M-RelyX Luting Plus | 110 | 27 | - | 15 |
| 3M-Vitrebond Plus LC | 114 | 28 | - | 18 |
| GC Fuji Lining LC | 135 | 26 | - | 12 |
| GC-Fuji Plus Lining Capsule | 156 | 31 | - | 15 |
Study Proving Device Meets "Acceptance Criteria":
The study primarily involves bench performance testing as summarized in the tables above, and a comparison to predicate devices. The "acceptance criteria" are implied to be that the device's performance aligns with or is superior to that of the already legally marketed predicate devices. The conclusion states that "Pulpdent RMGI Low Viscosity is substantially equivalent in design, composition, performance and intended use to the predicate products listed above," based on these comparisons and bench testing.
Non-Applicable Fields (for AI/ML device context):
The following fields are not relevant for this 510(k) submission for a non-AI/ML dental material. The document describes physical and chemical properties testing, not diagnostic or predictive performance of an algorithm.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The "test sets" would be material samples tested for physical properties in a lab setting. The document does not specify sample sizes for these bench tests, but this is standard practice for material testing, not clinical data.
- 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. Bench testing does not involve expert-established ground truth in this sense.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 for AI/ML image analysis.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench tests, the "ground truth" would be the measured physical properties based on standardized test methods.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
§ 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.