(6 days)
3M VitCal Liner/Base is indicated for lining and basing applications under dental restorations. 3M VitCal Liner/Base is also indicated for direct pulp capping.
3M VitCal liner/base is a two-part paste/paste, light-cured system. The paste/paste materials are contained in a Micro-Mix Syringe Dispensing System. This dispensing system provides simultaneous dispensing and mixing of each component for a consistent mix and direct application into the mouth. The composition is a combination of a resin-modified glass ionomer and calcium-based material. The first paste contains a radiopaque fluoro-aluminosilicate glass and calcium filler. The second paste contains a modified polyalkenoic acid. VitCal liner/base provides the major benefits of glass ionomer cements including adhesion to the tooth structure and sustained fluoride release. Additionally, VitCal linerbase offers a high pH environment and a combination of a prolonged working time with an on-demand set time achieved by light curing.
The provided text is a 510(k) Premarket Notification for a dental product, 3M™ VitCal Liner/Base. It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.
It is important to note that this document is for a DENTAL LINER/BASE material, NOT an AI-powered medical device for diagnosis or image analysis. Therefore, the requested information regarding AI study design, such as MRMC studies, expert adjudication for ground truth, sample sizes for training/test sets in an AI context, and effect sizes of human readers with AI assistance, is not applicable to this submission.
The acceptance criteria and "study" proving the device meets them, in this context, refer to bench testing of physical, chemical, and biological properties (biocompatibility) to demonstrate that the new dental material performs comparably or acceptably to existing predicate devices.
Here's the relevant information extracted from the document, tailored to the type of device:
1. Table of Acceptance Criteria and the Reported Device Performance (Bench Test Results):
| Physical Properties Acceptance Criteria | Units/Additional Details | 3M VitCal Liner/Base Reported Performance | TheraCal LC (Primary Predicate) Reported Performance | 3M Vitrebond Plus (Secondary Predicate) Reported Performance |
|---|---|---|---|---|
| Compressive Strength ≥ 69 MPa | MPa | 103 ± 10 | Could not be cured effectively | 102 ± 6 |
| Flexural Strength ≥ 10 MPa | MPa | 25 ± 3 | 16 ± 2 | 27 ± 1 |
| Surface Hardness (Barcol) ≥ 80% (0 mm) | % with curing light distance 0 mm (using ~950 mW/cm² for 20s) | 98 ± 8% | 84 ± 3% | 109 ± 15% |
| Surface Hardness (Barcol) ≥ 80% (7 mm) | % with curing light distance 7 mm (using ~950 mW/cm² for 20s) | 93 ± 3% | 60 ± 4% | 101 ± 6% |
| Surface Hardness (Barcol) ≥ 80% (0 mm) | % with curing light distance 0 mm (using ~400 mW/cm² for 30s) | 94 ± 4% | 92 ± 2% | |
| Surface Hardness (Barcol) ≥ 80% (7 mm) | % with curing light distance 7 mm (using ~400 mW/cm² for 30s) | 89 ± 11% | Not tested. | 101 ± 8% |
| Radiopacity ≥ 1.0 mm Aluminum Standard | mmAl | 1.52 ± 0.05 | 1.56 ± 0.01 | 1.33 ± 0.04 |
| Calcium Release > 0 µg/g (Pass/Fail) | Cumulative amount for seven days | Pass | Pass | Not applicable. |
| Fluoride Release > 0 µg/g (Pass/Fail) | Cumulative amount for seven days | Pass | Not applicable. | Pass |
| Phosphate Release > 0 µg/g (Pass/Fail) | Cumulative amount for seven days | Pass | Not applicable. | Not applicable. |
| Working Time > 1.5 minutes | minutes | 2.44 ± 0.0 | N/A, one part | 2.5 per IFU |
| Shear Bond Strength to Dentin > 4 MPa | MPa, adhesion to 3M Scotchbond Universal | 6 ± 3 | 2 ± 1 | 9 ± 3 |
| MPa, adhesion to 3M Adper Single Bond Plus Adhesive | 6 ± 2 | Not tested. | 13 ± 1 | |
| MPa, adhesion to 3M Scotchbond Multi-Purpose Plus Adhesive | 8 ± 3 | Not tested. | 13 ± 2 | |
| MPa, adhesion to Kuraray CLEARFIL™ SE BOND Adhesive | 6 ± 3 | Not tested. | 8 ± 3 | |
| Dentin Tubule Occlusion: Tag formation observed under SEM | Yes/No | Yes | Yes | Yes |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Bench Tests: The specific number of samples (e.g., n=5, n=10) for each individual bench test (e.g., compressive strength, flexural strength) is not explicitly detailed in this summary. However, standard deviations are provided for most quantitative measurements (e.g., 103 ± 10), implying multiple replicates were used for testing. For "Dentin Tubule Occlusion," it states "Only 1 lot of 3M VitCal was tested."
- Data Provenance: The data is generated from laboratory bench testing of the dental material. The document does not specify a country of origin for the testing, but the submitting company (3M ESPE Dental Products) is based in St. Paul, MN, USA. The testing is prospective in the sense that it's performed specifically to characterize the device for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This question is not applicable as the "test set" here refers to physical and chemical properties measured in a lab, not clinical images or patient data analyzed by experts.
- For biocompatibility assessment, it states: "A Diplomate of the American Board of Toxicology has assessed the safety of this product and has determined that it is safe for its intended use." This is an expert opinion on the safety, but not "ground truth" derived from patient data.
4. Adjudication Method for the Test Set:
- This question is not applicable as there is no expert reading or interpretation of "cases" involved. Performance is based on direct physical and chemical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was NOT done. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation, which is not the function of this dental liner/base material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not an algorithm. This is a physical dental material. The "standalone performance" is represented by the bench test results of the material itself.
7. The Type of Ground Truth Used:
- The "ground truth" for this device is based on established industry standards and physical/chemical measurements (e.g., ISO 9917-2 standards for dental cements, ASTM/ISO standards for mechanical properties, and analytical chemistry methods for ion release). For biocompatibility, it's based on toxicological assessments against established biological safety standards (e.g., ISO 10993).
8. The Sample Size for the Training Set:
- Not applicable. This device is a material, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. This device is a material, not an AI model, and therefore has no "training set."
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.