(269 days)
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- Luting metal crowns, bridge, inlay and including porcelain-fused-to-metal and composite-to-metal varieties
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- Luting resin crowns, bridges, inlays, onlays and veneers
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- Luting metal or non-metal/fiber posts
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- Luting orthodontic appliances
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- Luting porcelain inlays, onlays, crowns and veneers (includes alumina and zirconia)
The U-Cem™ Premium and the MAZIC® Cem are dual-cured self-adhesive resin cement. The U-Cem™ Premium and the MAZIC® Cem are the same product yet with different label design for different volume packages as shown below. The brand name, MAZIC® Cem, is specifically for 8.5g.
It is fluoride-releasing paste type, and has radiopaque. U-Cem™ Premium is available in both Automix and Double Dispenser types, and offers three different shades: Clear, Universal, and Opaque for esthetics.
It is used for cementation of ceramics, metals or composite inlays, onlays, crowns, bridges, posts and screws.
The provided document is a 510(k) premarket notification for a dental cement (U-Cem™ Premium & MAZIC® Cem). It describes the device, its intended use, and compares its performance to a predicate device (BisCem, K082449) to establish substantial equivalence.
This document does not describe a study involving an AI/Machine Learning device or a diagnostic device that would require the establishment of ground truth by experts, MRMC studies, or specific acceptance criteria related to classification metrics (e.g., sensitivity, specificity).
Instead, it focuses on the physical and performance properties of a dental cement, a tangible medical device. The "acceptance criteria" in this context refer to the device's ability to meet certain established standards and to demonstrate comparable performance to a legally marketed predicate device.
Therefore, many of the requested items (e.g., number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device submission.
However, I can extract the relevant "acceptance criteria" (which are performance specifications and compliance with standards) and the "reported device performance" from the document.
Overview of "Acceptance Criteria" and Reported Device Performance
For the U-Cem™ Premium & MAZIC® Cem dental cement, the "acceptance criteria" are implied by its compliance with recognized international standards for dental materials and its demonstration of comparable or superior physical properties to a predicate device. The study proves the device meets these criteria through a series of non-clinical performance tests and biocompatibility tests.
1. Table of Acceptance Criteria and Reported Device Performance
The device is deemed acceptable if its performance parameters meet or exceed those of the predicate device and comply with relevant ISO standards.
| Characteristic ("Acceptance Criteria" Basis) | Predicate Device (BisCem) Performance | Subject Device (U-Cem™ Premium / MAZIC® Cem) Performance | Comment / Compliance |
|---|---|---|---|
| Indications for Use | Match | Match | Substantially Equivalent |
| Principle of Operation | Dual cured | Dual cured | Substantially Equivalent |
| Working Time | Physically homogeneous & forming thin layer | Physically homogeneous & forming thin layer | Substantially Equivalent |
| Setting Time | 9 m 08 s | 2 m 12 s | Both meet ISO 4049 requirement. Subject device is faster, which is not an issue for substantial equivalence. |
| Compressive Strength | 189.15 MPa | 236.35 MPa | Subject device has higher strength. |
| Flexural Strength | 101.93 MPa | 135.87 MPa | Subject device has higher strength. |
| Film Thickness | 23 µm | 11 µm | Subject device has thinner film (generally desirable). |
| Shear Bond Strength: | Subject device generally superior or comparable. | ||
| - Composite - Dentin | 7.68 MPa | 12.85 MPa | Subject device higher. |
| - Composite - Enamel | 16.32 MPa | 19.16 MPa | Subject device higher. |
| - Glass Ceramic - Lithium disilicate | 5.49 MPa | 6.21 MPa | Subject device higher. |
| - Ceramic Aluminum oxide | 4.27 MPa | 7.28 MPa | Subject device higher. |
| - Metal | 4.38 MPa | 12.70 MPa | Subject device higher. |
| - Zirconia | 5.12 MPa | 9.05 MPa | Subject device higher. |
| Fluoride Release | 10.02 ppm | 2.42 ppm | Difference noted, but sufficient for claims. |
| Radio-opacity | None | 1.45 | Subject device has radiopacity. |
| Solubility | 1.53 µg/mm² | 0.87 µg/mm² | Subject device has lower solubility (generally desirable). |
| Polymerization Shrinkage | 4.18 % | 4.38 % | Comparable. |
| Chemical Composition | Amorphous silica (filler), Methacrylate based (resin) | Amorphous silica (filler), Methacrylate based (resin) | Substantially Equivalent. |
| Method of Application | Bonding agent not required | Bonding agent not required | Substantially Equivalent. |
| Ions Released | Fluoride | Fluoride | Substantially Equivalent. |
| Standard Conformed | ISO 4049 | ISO 4049 | Both conform. |
| Biocompatibility | Yes | Yes | Both biocompatible. |
| Use | Prescription / Hospital | Prescription / Hospital | Substantially Equivalent. |
| Delivery System | Dual-syringe (Automix type) | Dual syringe (Automix and Double Dispenser type) | Additional delivery system for subject device, but mixing ratio same. |
| Storage Condition | 2~8°C | 2~8°C | Substantially Equivalent. |
| Shade Options | Translucent, Opaque | Clear, Universal, Opaque | Subject device has more options. |
Study Details (Non-Applicable sections are explicitly stated)
Since this is a submission for a dental cement based on physical and chemical properties and comparison to a predicate device, the standard questions relating to AI/ML or diagnostic image analysis are largely not applicable.
2. Sample size used for the test set and the data provenance:
- The document implies that various samples of the U-Cem™ Premium & MAZIC® Cem were used for each physical, chemical, and biological test. Specific sample sizes for each test are not provided in this summary.
- The data provenance is from non-clinical bench testing and biocompatibility testing. The country of origin for the testing itself is not explicitly stated, but the manufacturer is Vericom Co., Ltd. from the Republic of Korea. The data is prospective in the sense that the tests were specifically performed for this submission to demonstrate substantial equivalence.
3. 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. Ground truth, in the AI/ML sense, is not established for this device. The "ground truth" for dental cement is its objective physical and chemical properties, measured using standardized laboratory methods (e.g., ISO standards).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for subjective human assessments, typically in diagnostic studies. The performance of this device is measured objectively through lab tests.
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:
- No, an MRMC comparative effectiveness study was not done. This is not relevant for a dental cement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or software device. The "standalone performance" refers to the intrinsic physical and chemical properties of the cement itself, as measured by the non-clinical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on objective measurements derived from standardized laboratory testing methods (e.g., ISO standards for dental materials) and direct comparison to the characteristics of a legally marketed predicate device.
8. The sample size for the training set:
- Not Applicable. This device is a manufactured product, not an AI/ML model that requires training data.
9. How the ground truth for the training set was established:
- Not Applicable. (See point 8)
§ 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.