(192 days)
Vertex cold-curing denture base materials are indicated for:
- Manufacture of full and partial dentures
- Repair of full and partial dentures
- Rebasing of full and partial dentures
- Relining of full and partial dentures
Vertex cold-curing denture base materials are self curing acrylic denture base materials composed of polymethyl methacrylate powder and a liquid consisting of methyl methacrylate and other ingredients. The polymer is shaded to simulate the color of gum tissue using pigments that are approved for alimentary or similar use and are Cadmium free. The devices covered in this submission are the Vertex Self Curing, Vertex Castavaria, and the Vertex Castapress denture base materials.
VertexTM Self Curing is a self-curing acrylic denture base material intended for the repair and relining of full and partial dentures, made by heat-curing acrylics. This acrylic can be polymerized in 10 minutes using a pressure vessel.
VertexTM Castavaria is a multifunctional self polymerizing denture base material intended as a pouring and as a repair acrylic. The advantages of this acrylic are: minimized shrinkage, color stability, stable polymerization cycle and the acrylic is pourable for a long period of time. In addition Vertex™ Castavaria can be worked and modeled over a relatively long period of time.
Vertex™ Castapress is a self polymerizing pouring/casting type denture base material also suitable for repair, relining, rebasing and extensions of partial dentures. The colour stability of the material is excellent because of the use of an unique accelerator system
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Vertex cold-curing denture base materials.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than a detailed clinical trial report for novel technologies. Therefore, some of the requested information (especially regarding aspects like expert adjudication, MRMC studies, or detailed training set information common in AI/software device submissions) is not applicable or present in this type of submission for a dental material.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Vertex cold-curing denture base materials are implicitly based on demonstrating substantial equivalence to the physical properties of the predicate devices. The study involved comparing key physical properties of the new devices (Vertex Self Curing, Vertex Castavaria, Vertex Castapress) against two legally marketed predicate devices: Probase Cold (K913655) and Major Repair (K082153).
The "acceptance criteria" are therefore considered to be performance within the range or comparable to the predicate devices for each physical property measured.
| Acceptance Criteria (Based on Predicate Devices) | Vertex Self Curing Reported Performance | Vertex Castavaria Reported Performance | Vertex Castapress Reported Performance | Met Criteria? |
|---|---|---|---|---|
| Flexural Strength: ≥ 63.44 MPa (Probase Cold) / ≥ 66.4 MPa (Major Repair) | 68 MPa | 79 MPa | 75 MPa | Yes (all models) |
| Flexural Modulus: ≥ 1832.00 MPa (Probase Cold) / ≥ 2217 MPa (Major Repair) | 2028 MPa | 2316 MPa | 2293 MPa | Yes (all models) |
| Water Absorption: Comparable to 21.2 µg/mm³ (Major Repair) | 20.3 µg/mm³ | 23.2 µg/mm³ | 22.1 µg/mm³ | Yes (comparable) |
| Water Solubility: Comparable to 1.4 µg/mm³ (Major Repair) | 1.8 µg/mm³ | 1.8 µg/mm³ | 1.19 ± 0.18 µg/mm³ | Yes (comparable) |
| Residual Monomer: ≤ 4.5% (Probase Cold) / ≤ 4.0% (Major Repair) | 3.76 ± 0.15% | 3.91 ± 0.05% | 3.22 ± 0.06% | Yes (all models) |
Note on "Met Criteria?": The determination of "Yes" is based on the new devices performing at or better than the reported values for the predicate devices where specific values are given, or being within a reasonable range for properties like water absorption/solubility where direct numerical cut-offs aren't explicitly stated but comparability is sought. The FDA's substantial equivalence determination confirms these criteria were met.
Study Details
-
Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample sizes (number of specimens) used for testing each physical property for the new devices or the predicates. Testing of dental materials typically involves a defined number of specimens per test according to relevant ISO standards (e.g., ISO 1567).
- Data Provenance: The data for the Vertex devices was generated by the submitter, Vertex Dental B.V. (The Netherlands). The nature of these tests (physical property measurements) is experimental/laboratory-based rather than retrospective or prospective clinical data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. The "ground truth" for physical properties of a material is established through standardized laboratory testing methods (e.g., flexural strength, water absorption using ISO standards), not through expert consensus or interpretation in the way one would for diagnostic images. The results are quantitative measurements.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are relevant for subjective assessments or classifications (e.g., in clinical trials or image interpretation) where human experts might disagree. For objective physical property measurements, standard laboratory protocols are followed, and results are quantitative.
-
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:
- This is not applicable. MRMC studies are specific to diagnostic devices, particularly those involving human interpretation of data (like medical images), often to evaluate the impact of AI assistance. This submission is for a dental material (denture base), not a diagnostic AI device.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. There is no algorithm or AI component in this dental material.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance evaluation consists of quantitative measurements of physical properties (e.g., flexural strength, water absorption) obtained through validated laboratory test methods compliant with international standards (e.g., ISO 1567, ISO 20795).
-
The sample size for the training set:
- This is not applicable. There is no "training set" as this is not a machine learning or AI device. The material properties are inherent to its chemical composition and manufacturing process, not learned from data.
-
How the ground truth for the training set was established:
- This is not applicable, as there is no training set.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.