(351 days)
DENU Composite Resin is indications for use in:
- Direct anterior and posterior restorations
- Core buildup
- Splinting
- Indirect anterior and posterior restorations including inlays, onlays and veneers
DENU Flow Resin is indications for use in:
- Class III restorations
- Class V restorations
- Small Class I restorations (non stress-bearing restorations)
- Pit and fissure sealing in molars and premolars
- Repair of small defects in esthetic indirect inlays
- Base/liner under direct restorations
DENU Composite Resin is light-cured composite resin which can be used in anterior and posterior teeth. This is classified into type 1, class 2, group 1 according to 4, ISO 4049:2019.
DENU Flow Resin is light-cured flowable composite resin which can be used in anterior and posterior teeth. This is classified into type 1, class 2 group 1 according to 4, ISO 4049:2019.
Please note: The provided document is a 510(k) summary for a dental resin material, not an AI/ML medical device. Therefore, many of the requested elements for describing AI/ML device studies (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable to this type of traditional medical device submission.
I will address the applicable acceptance criteria and study information as presented in the document for the DENU Composite Resin and DENU Flow Resin.
Here's the information extracted from the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents performance data for two devices: DENU Composite Resin and DENU Flow Resin, comparing them against predicate devices and indicating whether they meet acceptance criteria. The acceptance criteria are implicitly derived from the predicate device values and the referenced ISO standards (ISO 4049 and ISO 10993 series). The document states that "All the test results met the preset test criteria."
DENU Composite Resin
| Characteristic | Acceptance Criteria (Predicate range/description) | DENU Composite Resin Performance | Met Acceptance Criteria |
|---|---|---|---|
| Compressive strength | DEB Shade: 370.56 (15.13) MPa; T Shade: 394.01 (25.05) MPa | 187.4 (46) MPa | Yes (implied by "Both acceptance criteria") |
| Flexural strength | DEB Shade: 165.14 (13.59) MPa; T Shade: 157.98 (8.16) MPa | 135.74 (11.72) MPa | Yes (implied by "Both acceptance criteria") |
| Elastic modulus | DEB Shade: 11348 (271) MPa; T Shade: 9180 (431) MPa | 7950.5 (464.6) MPa | Yes (implied by "Both acceptance criteria") |
| Depth of cure | 2.60 (0.02) mm | A0: 3.86 (0.15) mm; U0: 3.43 (0.11) mm | Met |
| Filler particle size distribution | Silica: 20 nm; Zirconia: 4 to 11 nm; cluster filler: 0.6 to 10 microns | Silica: 16 nm; Glass: 4 µm | Met |
| Surface hardness | 78.664 (0.68) KHN | 43.86 (3.02) KHN | Met |
| Radio-opacity | 2.1 (0.0) mmAl | 3.2 mmAl | Met |
| Water sorption | 33.1 (2.1) µg/mm³ | 18.48 (0.84) µg/mm³ | Met |
| Solubility | 1.0 (0.7) µg/mm³ | 0.82 (0.76) µg/mm³ | Met |
| Curing time | 20 sec (for 2.0mm depth); 40 sec (for 1.5mm depth) | 20 sec | Met |
DENU Flow Resin
| Characteristic | Acceptance Criteria (Predicate range/description) | DENU Flow Resin Performance | Met Acceptance Criteria |
|---|---|---|---|
| Compressive strength | 317.82 (17.20) MPa | 277.4 (29.4) MPa | Met |
| Flexural strength | 120.96 (18.64) MPa | 105.24 (6.74) MPa | Met |
| Elastic modulus | 6815.80 (924.00) MPa | 8772.3 (558.1) MPa | Met |
| Depth of cure | 2.837 (0.13) mm | A0: 2.93 (0.05) mm; U0: 2.66 (0.05) mm | Met |
| Filler particle size distribution | Ytterbium trifluoride: 0.1 to 5.0 µm; Silica: 20 nm, 75 nm; Zirconia/silica cluster: 0.6 to 10 µm | Silica: 16 nm; Glass: 4 µm | Met |
| Surface hardness | 45.124 (0.16) KHN | 26.02 (1.83) KHN | Met |
| Radio-opacity | 1.70 (0.05) mmAl | 2.7 mmAl | Met |
| Water sorption | 24.87 (2.23) µg/mm³ to 28.32 (1.23) µg/mm³ | 25.24 (0.88) µg/mm³ | Met |
| Solubility | 3.22 (0.20) µg/mm³ to 9.77 (0.69) µg/mm³ | 1.52 (0.56) µg/mm³ | Met |
| Curing time | 20 sec (for 2.0mm depth); 40 sec (for 1.5mm depth) | 20 sec | Met |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of specimens) used for each physical property test. It mentions that "The following test articles were tested based on the referenced standard," which refers to ISO 4049 and ISO 10993. These standards typically specify the number of specimens required for each test. The data provenance is laboratory testing of the device itself, not clinical data from a specific country or retrospective/prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a material science study involving physical and chemical property testing, not an AI/ML device relying on expert consensus for ground truth. The "ground truth" is established by direct measurement of the material properties described in the ISO standards.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers or experts, which is not relevant to laboratory-based material property 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 material, not an AI/ML device, so no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a dental material, not an AI/ML algorithm.
7. The type of ground truth used
The ground truth for the performance testing is based on standardized laboratory measurements of physical and biological properties, as defined by the referenced ISO standards (ISO 4049 for physical properties, ISO 10993 for biocompatibility). These are objective, quantitative measurements rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
Not applicable. This is a traditional medical device (dental resin), not an AI/ML device that requires a training set. The device formulation and manufacturing process would be optimized through R&D, but not in the context of a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable. As there is no training set as understood in AI/ML, there is no ground truth established for it.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.