(154 days)
- Definitive cementation of inlays, onlays, crowns and bridges, in ceramic or zirconia, composite or metal; 2-3 unit Maryland bridges and 3-unit inlay/onlay bridges (to be avoided for patients with bruxism or periodontitis).
- Definitive cementation of endocanal posts.
- Definitive cementation of ceramic, zirconia, composite or metal restorations on implant abutments and natural teeth.
- Definitive cementation of zirconium oxide superstructures for two-unit abutments
OverCEM is dual-curing, self-adhesive resin luting cement. The components consists of Paste A and B, which are filled in a one-body syringe. Both pastes are automixed with a mixing tip. The operating principle of the device is based on two reactions, one self-curing. OverCEM is designed to strongly and stably connect reconstruction materials and endocanal posts to patients' teeth or implants.
The provided text describes the 510(k) summary for the OverCEM SA dental cement devices. While it details performance bench tests conducted, it does not explicitly state specific acceptance criteria for each test or a direct "study" proving the device meets all acceptance criteria in the format of a clinical study report with individual acceptance criteria for each test and its outcome. Instead, it presents a comparison table showing the reported performance of the applicant device (OverCEM) against the predicate device (G-CEM ONE).
However, I can extract the reported device performance from Section 7 ("Performance Bench Tests") and Section 12 ("Comparison of Technology") for the applicant device and infer that these values are presumed to meet internal or regulatory acceptance criteria, as the device received a 510(k) clearance.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, specific acceptance criteria for each test (e.g., "flexural strength must be X MPa or greater") are not explicitly stated in the document. However, the reported performance values for the OverCEM device are provided, and they are implicitly deemed acceptable for 510(k) clearance by the FDA based on substantial equivalence to the predicate.
| Performance Test | Reported OverCEM Device Performance (Applicant) | Predicate Device Performance (G-CEM ONE) | Notes |
|---|---|---|---|
| Diametral tensile strength | Not explicitly listed, but implied as part of "Performance Bench Tests" | Not explicitly listed | |
| Film thickness | 23.10 µm | 5 µm | The applicant device has a higher film thickness than the predicate. This difference was presumably deemed acceptable by the FDA for substantial equivalence. |
| Compression strength | Not explicitly listed, but implied as part of "Performance Bench Tests" | Not explicitly listed | |
| Working time | 90 seconds (at 23°C/73.4°F) / 01:30 (at 35°C/95°F) | 165 seconds | The applicant device has a shorter working time at 23°C compared to the predicate, and even shorter at 35°C. |
| Setting time | 240 seconds (declared in IFU, 200.40 test result) (at 23°C/73.4°F) / 04:00 (at 35°C/95°F) | 240 seconds | The applicant device's declared setting time is the same as the predicate's, with test results indicating slightly faster setting. |
| Flexural strength | 102.25 MPa | 150 MPa | The applicant device has a lower flexural strength than the predicate. This difference was presumably deemed acceptable by the FDA for substantial equivalence, possibly due to other compensating factors or falling within an acceptable range for the intended use. |
| Water sorption | 0.45 µm/mm³ | 0.0000025 µm/mm³ | The units for water sorption differ significantly between the applicant and predicate, making direct comparison difficult without clarification of units or magnitude. The applicant's value is much larger. |
| Solubility | 0.883 µm/mm³ | 0.0000016 µm/mm³ | Similar to water sorption, units or magnitude differences make direct comparison challenging. The applicant's value is much larger. |
| Color stability | Excellent overall behaviour in colour stability tests | Excellent colour stability | Both devices report excellent color stability. |
| Radio-Opacity | The OverCEM devices are radio-opaque. | No information on the radio-opacity of the device (for predicate) | The applicant device features radio-opacity, a characteristic for which information on the predicate is not provided in this document. |
| Adhesive bond strength (Dentin) | 12.95 ± 2.22 MPa | 9.24 ± 2.06 MPa | The applicant device shows higher adhesive bond strength to dentin. |
| Adhesive bond strength (Enamel) | 29.62 ± 7.75 MPa | 26.45 ± 7.72 MPa | The applicant device shows higher adhesive bond strength to enamel. |
| Adhesive bond strength (Zirconia) | 44.21 ± 6.53 MPa | 32.45 ± 3.09 MPa | The applicant device shows significantly higher adhesive bond strength to zirconia. |
| Adhesive bond strength (Glass Ceramic) | 31.40 ± 5.68 MPa | 19.55 ± 5.06 MPa | The applicant device shows significantly higher adhesive bond strength to glass ceramic. |
| Adhesive bond strength (Composite) | 31.27 ± 3.51 MPa | 22.85 ± 4.77 MPa | The applicant device shows higher adhesive bond strength to composite. |
| Adhesive bond strength (Metal) | 34.84 ± 4.97 MPa | 29.34 ± 4.71 MPa | The applicant device shows higher adhesive bond strength to metal. |
| Biocompatibility | Acceptable based on ISO 10993-1, 10993-5, 10993-10 tests | Not explicitly detailed, but implied as legally marketed | In vitro cytotoxicity, skin sensitization, and intracutaneous reactivity tests were performed and found acceptable for OverCEM. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each individual test. The document mentions "The device has been tested according to ISO 4049:2009... ISO 13116:2015... ISO 7491:2000... and ISO 29022:2013." These ISO standards typically specify minimum sample sizes for their respective tests, but the document does not report the specific number of samples used in these tests for OverCEM.
- Data Provenance: The document states, "Data for adhesion strength were obtained from a test performed by Overfibers S.r.l according to ISO 29022:2013." This indicates that at least the adhesion strength data is prospective and conducted by the manufacturer (Overfibers S.r.l.) based in Italy for the applicant device. The provenance for other bench tests is not explicitly stated beyond "The device has been tested according to..."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes physical and chemical performance bench tests of a dental cement, not a diagnostic device or software requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as the document describes physical and chemical performance bench tests, not a diagnostic device or software requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing has been performed on this device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a dental cement, not a software algorithm. The performance tests are for the physical and chemical properties of the material itself.
7. The Type of Ground Truth Used
For the physical and chemical property tests, the "ground truth" is established by adherence to international standards (e.g., ISO standards) for dental materials testing. The outcomes of these standardized tests (e.g., MPa for flexural strength, µm for film thickness) are the "ground truth" for the device's performance attributes. For biocompatibility, the ground truth is compliance with ISO 10993 series for biological evaluation of medical devices.
8. The Sample Size for the Training Set
Not applicable. This device is a dental cement, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a dental cement, not an AI/ML algorithm that requires a training set and established ground truth.
§ 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.