(323 days)
Allcem and Allcem Core are indicated for the cementation of the tooth structure. It can be used for luting:
- · Porcelain fused-to-metal crowns and bridges;
- · Metal crowns, bridges, inlays and onlays (high noble, noble, and base metals);
- · Crowns and bridges with minimal tooth structure;
- · Maryland bridges (resin bonded bridges);
- · All ceramic/porcelain and pre-cured composite crowns, bridges, inlays and onlays;
- · Endodontic posts;
-
- Only for Allcem Core: Core build-up.
ALLCEM: Allcem is a dual-curing radiopaque permanent resin cement system indicated for the cementation of indirect restorations to the tooth structure. The product is composed of a base paste and a catalyst paste, stored in a double-body syringe, which allows releasinq the correct proportion of each paste (1:1) and separating syringes of base paste and catalyst paste. Allcem is composed of methacrylate monomers, such as TEGDMA and BisEMA, inorganic load, photoinitiators, coinitiators, catalysts and pigments. Allcem presents adjusted viscosity allowing the formation of fine layers of cement with the appropriate covering of the parts.
ALLCEM CORE: Allcem Core is a dual-curing resin cement specially conceived for the adhesive cementation of intraradicular posts, crowns and core build-up . The product is commercialized in a double-body syringe, which facilitates obtaining the correct mixing proportions of the two pastes (1:1), and eases clinical procedures. By using an self-mixing tip with an applying nozzle (intracanal tip), it is possible to apply the cement inside the root canal and easily cement the post. The same tip can be used to add material to the crown region of the post to build up the core, Allcem Core is a composite of methacrylate monomers such as BisGMA, BisEMA and TEGDMA, inorqanic load, photoinitiators, coinitiators, catalysts and pigments. The cement associates the necessary flow for applications in canals with the ideal thixotropy for core build-ups.
The provided text outlines the acceptance criteria and the study that demonstrates the Dentscare LTDA 'Allcem' and 'Allcem Core' dental cements meet these criteria. The information is extracted directly from the "Non-clinical Testing" section of the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Specification) | Reported Device Performance (Results) |
|---|---|---|
| Flexural Strength (dual cure) | ≥ 50 MPa (according to EN ISO 4049) | Average: 145.4 MPa (All results greater than threshold, conformant) |
| Flexural Strength (chemical curing) | ≥ 50 MPa (according to EN ISO 4049) | Average: 127.7 MPa (All results greater than threshold, conformant) |
| Film Thickness | ≤ 50 µm (according to EN ISO 4049) | Sample 1: 31 µm, Sample 2: 36 µm, Sample 3: 38 µm, Sample 4: 32 µm, Sample 5: 35 µm (All comply with EN ISO 4049) |
| Working Time | ≥ 60 seconds (according to EN ISO 4049) | > 60 seconds (ideal time for professional work and within standard value) |
| Setting Time | Maximum 10 minutes (according to EN ISO 4049) | Around 7 minutes (meets specification) |
| Water Sorption | Maximum 40 µg/mm³ (according to EN ISO 4049) | Complies with specification |
| Water Solubility | Maximum 7.5 µg/mm³ (according to EN ISO 4049) | Complies with specification |
| Radiopacity | ≥ 1 mm (equivalent to aluminum for a 1.0 mm thick specimen, according to ISO 4049) | Values found in specimens are between the second and third scale of the aluminum part, proving the material is radiolucent according to ISO 4049. |
| Accelerated Stability Studies | Designed to accelerate possible chemical degradation and/or physical changes in forced storage conditions. | Shelf-life of 2 years at 25 °C for Allcem product confirmed after 129 days. |
| Long-Term Stability (Shelf) Evaluation | Designed to verify physical and chemical characteristics during expected shelf life. | Shelf-life of 2 years at 25 °C for Allcem product confirmed after 24 months. |
| Adhesive Resistance to Metal Surfaces, Pins, Ceramics, and Laboratory Resin (Shear Bond Strength) | Near or higher than competitors (for general adhesive resistance). ISO 29022 specifies a shear test method. | "Excellent adhesion results" (although direct adhesion to tooth structure is promoted by adhesives, these tests demonstrate good performance). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Flexural Strength (dual cure): 5 specimens (CP 1-5)
- Sample Size for Flexural Strength (chemical curing): 5 specimens (CP 1-5)
- Sample Size for Film Thickness: 5 samples (Sample 1-5)
- Sample Size for Accelerated Stability Studies: Not explicitly stated, but the study period was 129 days.
- Sample Size for Long-Term Stability (Shelf) Evaluation: Not explicitly stated, but the study period was 24 months.
- Sample Size for other tests (Working time, Setting time, Water sorption and solubility, Radiopacity, Shear Bond Strength): Not explicitly stated, but tests were performed, and results are reported as meeting specifications.
- Data Provenance: The document does not specify the country of origin of the data for these non-clinical tests. The tests appear to be laboratory-based and conducted internally or by a contracted lab. The document does not indicate if the data is retrospective or prospective, but as it describes "tests were performed," it suggests a prospective testing approach for these specific evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section describes non-clinical, in-vitro testing based on established international standards (ISO and EN ISO). There is no mention of human experts establishing a "ground truth" for these measurements, as the ground truth is defined by the objective quantitative thresholds set by the standards themselves.
4. Adjudication Method for the Test Set
Not applicable for non-clinical, in-vitro physical and chemical property testing. The results are compared directly against the quantitative specifications of recognized international standards.
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 document pertains to a dental cement, not an AI-powered diagnostic or assistive device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This document pertains to a physical dental cement, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is represented by the quantitative specifications defined by recognized international standards, primarily EN ISO 4049, as well as ISO 10993 series for biocompatibility. For instance, for flexural strength, the ground truth is established by the standard's requirement of "≥ 50 MPa."
8. The Sample Size for the Training Set
Not applicable. This is a physical product, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical dental cement.
§ 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.